Maternal and Neonatal Outcomes of Women with Preeclampsia and Eclampsia at a Tertiary Care Center

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Hediye Dağdeviren

2015-12-01

Full Text Available Aim: Preeclampsia is a multisystem disorder of unknown etiology and one of the leading causes of maternal, fetal and neonatal mortality and morbidity. Adverse outcomes can be improved by early identification of the disease and timely referral to a tertiary center. The aims of this study were to evaluate the outcomes of preeclampsia-eclampsia cases and share our experiences in a tertiary center. Methods: The study conducted by retrospectively analyzing the data of 350 women who gave birth between 2008 and 2013 at a tertiary care center. Results: The mean age of the enrolled women was 35 years, the mean gestational age at delivery-36 weeks, the mean birth weight-2.73 kg, and the mean platelet count was 204.000/ mm3. The incidence of preterm deliveries was 66.6%. Severe preeclampsia was noted in 29.4% of cases. Neonatal intensive care unit admissions were seen in 10.6% of cases. A total of 22.9% of these women had vaginal deliveries, while the other 77.1% underwent cesarean section. High systolic blood pressure and elevated serum alanine and aspartate aminotransferase values had significant independent effects of differentiating between mild and severe preeclampsia. Conclusion: Fetomaternal morbidity and mortality rates associated with hypertensive disorders are alarming, especially in developing countries. As such, the high-risk obstetric population should be screened earlier in pregnancy. A system allowing early referral in these cases should be created. (The Medical Bulletin of Haseki 2015; 53:143-6

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

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Lawrie, Theresa A; Betrán, Ana Pilar; Singata-Madliki, Mandisa; Ciganda, Alvaro; Hofmeyr, G Justus; Belizán, José M; Purnat, Tina Dannemann; Manyame, Sarah; Parker, Catherine; Cormick, Gabriela

2017-10-26

The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low

Maternal and perinatal outcome of eclampsia in tertiary health institution in Southeast Nigeria.

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Adinma, Echendu Dolly

2013-01-01

To evaluate the maternal and perinatal outcome in patients with eclampsia at Nnamdi-Azikiwe-University-Teaching-Hospital (NAUTH), Nnewi, Nigeria. A retrospective study of cases of eclampsia managed at NAUTH over a 10 year period - 1st January, 2000 to 31st December, 2009. Maternal outcome was measured in terms of complications and maternal death. Foetal outcome was assessed in terms of low birth weight, pre-term births, low apgar score, and perinatal deaths. There were 57 cases of eclampsia out of a total of 6,262 deliveries within the study period, giving a prevalence of 0.91%. Majority, 71.7%, had caesarean section. There were 17.4% maternal deaths mainly from pulmonary oedema, 6 (13.0%), acute renal failure, 4 (8.7%), and coagulopathy, 3 (6.5%). Perinatal deaths were 25.5% as a result of prematurity, 42 (82.4%), and low birth weight, 36 (70.6%). Twenty-one (41.2%) of the new born had Apgar score of less than seven at 5 min while 13.0% were severely asphyxiated. Eclampsia was associated with high maternal and perinatal morbidity and mortality in this study. There is need to review existing protocol on eclampsia management with emphasis on appropriate health education of pregnant mothers, good antenatal care, early diagnosis of pre-eclampsia with prompt treatment.

A randomized controlled trial of pre-conception treatment for periodontal disease to improve periodontal status during pregnancy and birth outcomes.

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Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu

2013-12-09

Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized controlled trial (RCT) has examined if treating periodontal disease before pregnancy reduces adverse birth outcomes. This study aims to examine if the pre-conception treatment of periodontal disease will lead to improved periodontal status during late pregnancy and subsequent birth outcomes. A sample of 470 (235 in each arm of the study) pre-conception women who plan to conceive within one year and with periodontal disease will be recruited for the study. All participants will be randomly allocated to the intervention or control group. The intervention group will receive free therapy including dental scaling and root planning (the standard therapy), supragingival prophylaxis, and oral hygiene education. The control group will only receive supragingival prophylaxis and oral hygiene education. Women will be followed throughout their pregnancy and then to childbirth. The main outcomes include periodontal disease status in late pregnancy and birth outcomes measured such as mean birth weight (grams), and mean gestational age (weeks). Periodontal disease will be diagnosed through a dental examination by measuring probing depth, clinical attachment loss and percentage of bleeding on probing (BOP) between gestational age of 32 and 36 weeks. Local and systemic inflammatory mediators are also included as main outcomes. This will be the first RCT to test whether treating periodontal disease among pre-conception women reduces periodontal disease during pregnancy and prevents adverse birth outcomes. If

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

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Dunkley David

2008-09-01

Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

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Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2008-01-01

Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues) in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues) intervention or to an attention control (Care) condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will provide important information

The role of maternal serumbeta-HCG and PAPP-A levels at gestational weeks 10 to 14 in the prediction of pre-eclampsia

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Ozdamar, Ozkan; Gun, Ismet; Keskin, Ugur; Kocak, Necmettin; Mungen, Ercument

2014-01-01

Objective: We aimed to detect whether maternal serum free β-hCG and PAPP-A levels and NT measurements vary between normal pregnancies and those that subsequently develop pre-eclampsia and to evaluate the role of these screening serum analytes in the prediction of pre-eclampsia. Methods: Using a case-control study design, we identified all women who had been screened by double test within 11+0 and 13+6 weeks of gestation and who had developed pre-eclampsia during the subsequent pregnancy course, over a 6-year period between January 2006 and December 2012 at two tertiary referral hospital. All women who had undergone a double test during that time, without a diagnosis of pre-eclampsia and who had not had any adverse obstetric outcomes, were also identified, and three women among them were randomly selected as controls for each case. Maternal and neonatal data were abstracted from the medical records and PAPP-A, β-hCG, NT and CRL MoM values were compared between the two groups. Results: Although β-hCG values show no statistically significant difference (p=0.882), PAPP-A levels were significantly reduced in the pre-eclampsia group compared to the control group (p<0.001). NT and CRL values showed no significant difference between the two groups (p=0.674 and p=0.558, respectively). Conclusion: Measuring PAPP-A in the first trimester may be useful in the prediction of pre-eclampsia. PMID:24948981

Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol.

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Khowaja, Asif R; Mitton, Craig; Bryan, Stirling; Magee, Laura A; Bhutta, Zulfiqar A; von Dadelszen, Peter

2015-05-26

Globally, hypertensive disorders of pregnancy, particularly pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. The Community Level Interventions for Pre-eclampsia (CLIP) Trial evaluates a package of care applied at both community and primary health centres to reduce maternal and perinatal disabilities and deaths resulting from the failure to identify and manage pre-eclampsia at the community level. Economic evaluation of health interventions can play a pivotal role in priority setting and inform policy decisions for scale-up. At present, there is a paucity of published literature on the methodology of economic evaluation of large, multi-country, community-based interventions in the area of maternal and perinatal health. This study protocol describes the application of methodology for economic evaluation of the CLIP in South Asia and Africa. A mixed-design approach i.e. cost-effectiveness analysis (CEA) and qualitative thematic analysis will be used alongside the trial to prospectively evaluate the economic impact of CLIP from a societal perspective. Data on health resource utilization, costs, and pregnancy outcomes will be collected through structured questionnaires embedded into the pregnancy surveillance, cross-sectional survey and budgetary reviews. Qualitative data will be collected through focus groups (FGs) with pregnant women, household male-decision makers, care providers, and district level health decision makers. The incremental cost-effectiveness ratio will be calculated for healthcare system and societal perspectives, taking into account the country-specific model inputs (costs and outcome) from the CLIP Trial. Emerging themes from FGs will inform the design of the model, and help to interpret findings of the CEA. The World Health Organization (WHO) strongly recommends cost-effective interventions as a key

MATERNAL OUTCOME IN PREGNANCY INDUCED HYPERTENSION IN A TEACHING HOSPITAL IN A RURAL AREA IN TELANGANA

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Kavitha Reddy Kothapally

2016-09-01

Full Text Available AIM To analyse the maternal outcome in pregnancy induced hypertension and improve the management strategies. INTRODUCTION Pregnancy induced hypertension is a medical disease peculiar to pregnancy, making pregnancy a high risk condition. Among medical disorders complicating pregnancy, it stands next to anaemia in prevalence. It is responsible for majority of the maternal morbidity and mortality. It also has an adverse perinatal outcome. Hence, early detection and timely intervention of women with pregnancy induced hypertension is important for good maternal and perinatal outcome. MATERIAL & METHODS The present Prospective Observational study was done from April 2015 to February 2016 in the department of obstetrics & gynaecology at Bhaskar medical college and general hospital, Yenkepally, Moinabad, Telangana. A total of 102 pregnant women with pregnancy induced hypertension were enrolled into the study. Demographic details like age, parity, previous obstetric history of pregnancy induced hypertension and diabetes, past history of polycystic ovarian disease, treatment for infertility, gestational age at which hypertension developed in the present pregnancy were noted. Relevant investigations were performed. Gestational age of delivery, mode of delivery and maternal complications were noted. RESULTS The incidence of pregnancy induced hypertension was 4% in the study population. About 59.8% developed pregnancy induced hypertension in the third trimester. Out of this, 64.7% cases were gestational hypertension and 35.3% cases were preeclampsia. Nearly half (41.7% of preeclampsia cases were severe preeclampsia. Postpartum haemorrhage is the commonest complication (13.7%, next being imminent eclampsia (7.8%, abruption (4.9%, eclampsia (3.9% and HELLP syndrome (0.98%. 80% of cases could be delivered beyond 37 weeks of gestational age. 71.57% of cases had lower segment caesarean section for indicated conditions. More than half of pregnancy induced

Effects of aerobic exercise training on maternal and neonatal outcome: a randomized controlled trial on pregnant women in Iran

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Ghodsi, Z.; Asltoghiri, M.

2014-01-01

Objective: To assess the effect of aerobic exercise training on maternal and neonatal outcome. Methods: The case-control study was conducted between January and July, 2011. It was approved by the Research Ethics Committee of Toyserkan Azad University, and data was collected at prenatal clinics and delivery centres located in Hamedan, Iran. It comprised 80 pregnant women between 20-26 weeks of gestation randomly assigned to two equal and matching groups of cases and controls. The intervention group did exercise continuously on a bicycle ergometre for 15 minutes, three times a week; the intensity being 50-60% of maximal heart rate. The control group did not do any exercise training. All information was obtained from the clinics, delivery centres, and from the reports of delivery room midwives. Results: No statistically significant difference was found between the two groups in gestational weight gain, pregnancy length, mode of delivery, first and second stage of labour, perineal tear, and 1st and 5th min Apgar score. Mean neonatal weight was significantly less in the intervention group than the control group (p<0.001). Conclusion: Exercising on a bicycle ergometer during pregnancy seems to be safe for the mother and the neonate. (author)

Estimation of proteinuria as a predictor of complications of pre-eclampsia: a systematic review

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Zamora Javier

2009-03-01

Full Text Available Abstract Background Proteinuria is one of the essential criteria for the clinical diagnosis of pre-eclampsia. Increasing levels of proteinuria is considered to be associated with adverse maternal and fetal outcomes. We aim to determine the accuracy with which the amount of proteinuria predicts maternal and fetal complications in women with pre-eclampsia by systematic quantitative review of test accuracy studies. Methods We conducted electronic searches in MEDLINE (1951 to 2007, EMBASE (1980 to 2007, the Cochrane Library (2007 and the MEDION database to identify relevant articles and hand-search of selected specialist journals and reference lists of articles. There were no language restrictions for any of these searches. Two reviewers independently selected those articles in which the accuracy of proteinuria estimate was evaluated to predict maternal and fetal complications of pre-eclampsia. Data were extracted on study characteristics, quality and accuracy to construct 2 × 2 tables with maternal and fetal complications as reference standards. Results Sixteen primary articles with a total of 6749 women met the selection criteria with levels of proteinuria estimated by urine dipstick, 24-hour urine proteinuria or urine protein:creatinine ratio as a predictor of complications of pre-eclampsia. All 10 studies predicting maternal outcomes showed that proteinuria is a poor predictor of maternal complications in women with pre-eclampsia. Seventeen studies used laboratory analysis and eight studies bedside analysis to assess the accuracy of proteinuria in predicting fetal and neonatal complications. Summary likelihood ratios of positive and negative tests for the threshold level of 5 g/24 h were 2.0 (95% CI 1.5, 2.7 and 0.53 (95% CI 0.27, 1 for stillbirths, 1.5 (95% CI 0.94, 2.4 and 0.73 (95% CI 0.39, 1.4 for neonatal deaths and 1.5 (95% 1, 2 and 0.78 (95% 0.64, 0.95 for Neonatal Intensive Care Unit admission. Conclusion Measure of proteinuria is a

Using clinical symptoms to predict adverse maternal and perinatal outcomes in women with preeclampsia: data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study.

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Yen, Tin-Wing; Payne, Beth; Qu, Ziguang; Hutcheon, Jennifer A; Lee, Tang; Magee, Laura A; Walters, Barry N; von Dadelszen, Peter

2011-08-01

Preeclampsia is a leading cause of maternal morbidity. The clinical challenge lies in predicting which women with preeclampsia will suffer adverse outcomes and would benefit from treatment, while minimizing potentially harmful interventions. Our aim was to determine the ability of maternal symptoms (i.e., severe nausea or vomiting, headache, visual disturbance, right upper quadrant pain or epigastric pain, abdominal pain or vaginal bleeding, and chest pain or dyspnea) to predict adverse maternal or perinatal outcomes. We used data from the PIERS (Pre-eclampsia Integrated Estimate of RiSk) study, a multicentre, prospective cohort study designed to investigate the maternal risks associated with preeclampsia. Relative risks and receiver operating characteristic (ROC) curves were assessed for each preeclampsia symptom and outcome pair. Of 2023 women who underwent assessment, 52% experienced at least one preeclampsia symptom, with 5.2% and 5.3% respectively experiencing an adverse maternal or perinatal outcome. No symptom and outcome pair, in either of the maternal or perinatal groups, achieved an area under the ROC curve value > 0.7, which would be necessary to demonstrate a discriminatory predictive value. Maternal symptoms of preeclampsia are not independently valid predictors of maternal adverse outcome. Caution should be used when making clinical decisions on the basis of symptoms alone in the preeclamptic patient.

Tratamento da pré-eclâmpsia baseado em evidências Pre-eclampsia treatment according to scientific evidence

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Carlos Noronha Neto

2010-09-01

. Currently, the best treatment for forms of pre-eclampsia is being discussed at different times in pregnancy and puerperium, with the objective to reduce the high rates of maternal and fetal morbidity and mortality. Considering the pathophysiology of the event, anticipation of delivery is the best treatment for pre-eclampsia. The use of magnesium sulfate is recommended in all cases of severe pre-eclampsia and eclampsia for prevention and treatment of seizures. Likewise, treatment of hypertensive crises is recommended. Hydralazine, nifedipine and labetalol have been the most commonly used drugs for this purpose, but their use depends on the familiarity of the treating physician. Antenatal corticoid therapy is indicated whenever there is an imminent risk of preterm delivery between 24 and 34 weeks. In contrast, there is insufficient evidence to recommend bed rest and routine plasma volume expansion, and there is an urgent need for randomized clinical trials to determine whether maintenance antihypertensive treatment in pregnant women has benefits or risks for mothers and fetuses in all clinical forms of disease, particularly in cases of pure pre-eclampsia.

Maternal serum bisphenol A levels and risk of pre-eclampsia: a nested case–control study

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Ye, Yunzhen; Zhou, Qiongjie; Feng, Liping; Wu, Jiangnan; Xiong, Yu; Li, Xiaotian

2017-01-01

Abstract Background Although recent studies have indicated the potential adverse effects of maternal bisphenol A (BPA) exposure on pregnancy such as increasing the risk of pre-eclampsia, epidemiological evidence is limited. We aimed to evaluate the relationship between maternal BPA exposure and the risk of pre-eclampsia. Methods We conducted a nested case–control study among 173 women (74 cases of pre-eclampsia and 99 controls). BPA concentrations were measured using liquid chromatography-mass spectrometry in the maternal serum samples collected during 16–20 gestational weeks. Multivariate logistic models were used to examine the relationship between maternal serum BPA concentrations and the risk of pre-eclampsia. Results BPA was detectable (>0.1 µg/l) in 78.6% of the maternal serum samples at three levels: low (4.44 µg/l). BPA concentrations were significantly higher in the serum samples collected from the pre-eclampsia cases than those from controls (median: 3.40 vs. 1.50 µg/l, P < 0.01). With adjustment for maternal age, primiparous and BMI, the odds of developing pre-eclampsia were significantly elevated in subjects with high serum BPA levels compared with those with low levels (adjusted OR = 16.46, 95%CI = 5.42–49.85) regardless of subcategories of pre-eclampsia including severity and onset time. Among the pre-eclampsia subjects, the maternal serum concentration of BPA was not different between the early- and late-onset subjects (median: 3.09 vs. 3.50 µg/l, P = 0.57), but surprisingly higher in mild pre-eclampsia subjects compared with severe pre-eclampsia subjects (median: 5.20 vs. 1.80 µg/l, P < 0.01). Conclusions These results demonstrated that maternal exposure to high level of BPA could be associated with an increased risk of pre-eclampsia. PMID:29186464

Maternal serum bisphenol A levels and risk of pre-eclampsia: a nested case-control study.

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Ye, Yunzhen; Zhou, Qiongjie; Feng, Liping; Wu, Jiangnan; Xiong, Yu; Li, Xiaotian

2017-12-01

Although recent studies have indicated the potential adverse effects of maternal bisphenol A (BPA) exposure on pregnancy such as increasing the risk of pre-eclampsia, epidemiological evidence is limited. We aimed to evaluate the relationship between maternal BPA exposure and the risk of pre-eclampsia. We conducted a nested case-control study among 173 women (74 cases of pre-eclampsia and 99 controls). BPA concentrations were measured using liquid chromatography-mass spectrometry in the maternal serum samples collected during 16-20 gestational weeks. Multivariate logistic models were used to examine the relationship between maternal serum BPA concentrations and the risk of pre-eclampsia. BPA was detectable (>0.1 µg/l) in 78.6% of the maternal serum samples at three levels: low (4.44 µg/l). BPA concentrations were significantly higher in the serum samples collected from the pre-eclampsia cases than those from controls (median: 3.40 vs. 1.50 µg/l, P < 0.01). With adjustment for maternal age, primiparous and BMI, the odds of developing pre-eclampsia were significantly elevated in subjects with high serum BPA levels compared with those with low levels (adjusted OR = 16.46, 95%CI = 5.42-49.85) regardless of subcategories of pre-eclampsia including severity and onset time. Among the pre-eclampsia subjects, the maternal serum concentration of BPA was not different between the early- and late-onset subjects (median: 3.09 vs. 3.50 µg/l, P = 0.57), but surprisingly higher in mild pre-eclampsia subjects compared with severe pre-eclampsia subjects (median: 5.20 vs. 1.80 µg/l, P < 0.01). These results demonstrated that maternal exposure to high level of BPA could be associated with an increased risk of pre-eclampsia. © The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association.

A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China.

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Zhang, Hongyu; Huang, Shurong; Guo, Xiaolan; Zhao, Ningning; Lu, Yujing; Chen, Min; Li, Yingxia; Wu, Junqin; Huang, Lihua; Ma, Fenglan; Yang, Yuhong; Zhang, Xiaoli; Zhou, Xiaoyu; Guo, Renfei; Cai, Wenzhi

2017-07-01

the supine position is the most frequently offered for birth delivery in China and many other countries, but the hands-and-knees position is now gaining prominence with doctors in China. This study aims to examine the differences in maternal and neonatal outcomes among low-risk women who gave birth either in the hands-and-knees position or the supine position. a randomised controlled trial was conducted in 11 hospitals in China from May to December in 2012. In total, 1400 women were recruited and randomly allocated to either the experimental group (n=700, 446 completed the protocol) who delivered in hands-and-knees position and the control group (n=700, 440 completed the protocol) who delivered in supine position. Women who could not maintain the randomised position during the second stage of labour were allowed to withdraw from the study. The primary maternal outcome measured was rate of episiotomy. Secondary outcomes included degree of perineum laceration, rate of emergency caesarean section, rate of shoulder dystocia, and duration of labour, postpartum bleeding, neonatal Apgar score, and the rate of neonatal asphyxia. Because outcome data were only collected for women who gave birth in the randomised position, per-protocol analyses were used to compare groups. The primary outcome, episiotomy, was also compared between groups using logistic regression adjusting for maternal age，gestational age at birth, whether the woman was primiparous, the process of second stage of labour and birthweight. as compared with the control group, the experimental group had lower rates of episiotomy and second-degree perineum laceration (including episiotomy), and higher rates of intact perineum and first-degree perineum laceration, with a longer duration of second stage of labour. No significant differences were found in the amount of postpartum bleeding, shoulder dystocia, neonatal asphyxia and neonatal Apgar scores at 1minute and 5minutes. Adjusted for maternal age, gestational

Heart Disease, Hypertension, Gestational Diabetes Mellitus, and Preeclampsia/Eclampsia in Mothers With Juvenile Arthritis: A Nested Case-Control Study.

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Feldman, Debbie E; Vinet, Évelyne; Bérard, Anick; Duffy, Ciarán; Hazel, Beth; Meshefedjian, Garbis; Sylvestre, Marie-Pierre; Bernatsky, Sasha

2017-02-01

To determine whether women with a history of juvenile arthritis are at higher risk for heart disease and hypertension and for developing adverse maternal outcomes: gestational diabetes mellitus, maternal hypertension, and preeclampsia/eclampsia. We designed a nested case-control study from a cohort of first-time mothers with prior physician billing codes suggesting juvenile arthritis, and a matched comparison group without juvenile arthritis. For the nested case-control design, we selected 3 controls for each case for the outcomes of heart disease (n = 403), prepregnancy hypertension (n = 66), gestational diabetes mellitus (n = 285), maternal hypertension (n = 561), and preeclampsia/eclampsia (n = 236). We used conditional logistic regression, adjusting for maternal age and education. Having juvenile arthritis was associated with heart disease (odds ratio [OR] 2.44 [95% confidence interval (95% CI) 1.15-5.15]) but not with gestational hypertension, diabetes mellitus, or preeclampsia/eclampsia. All 66 cases of prepregnancy hypertension had juvenile arthritis. Having prepregnancy hypertension was strongly associated with preeclampsia/eclampsia (OR 8.05 [95% CI 2.69-24.07]). Women with a history of juvenile arthritis had a higher risk of heart disease. This risk signals the potential importance of cardiac prevention strategies in juvenile arthritis. As this was a retrospective study, it was not possible to correct for some relevant potential confounders. Further studies should assess the impact of medications, disease severity, and other factors (e.g., obesity) on cardiac outcomes in juvenile arthritis. © 2016, American College of Rheumatology.

Magnesium sulphate and other anticonvulsants for women with pre-eclampsia.

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Duley, Lelia; Gülmezoglu, A Metin; Henderson-Smart, David J; Chou, Doris

2010-11-10

Eclampsia, the occurrence of a seizure (fit) in association with pre-eclampsia, is rare but potentially life-threatening. Magnesium sulphate is the drug of choice for treating eclampsia. This review assesses its use for preventing eclampsia. To assess the effects of magnesium sulphate, and other anticonvulsants, for prevention of eclampsia. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (4 June 2010), and the Cochrane Central Register of Controlled Trials Register (The Cochrane Library 2010, Issue 3). Randomised trials comparing anticonvulsants with placebo or no anticonvulsant, or comparisons of different drugs, for pre-eclampsia. Two authors assessed trial quality and extracted data independently. We included 15 trials. Six (11,444 women) compared magnesium sulphate with placebo or no anticonvulsant: magnesium sulphate more than a halved the risk of eclampsia (risk ratio (RR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; number needed to treat for an additional beneficial outcome (NNTB) 100, 95% CI 50 to 100), with a non-significant reduction in maternal death (RR 0.54, 95% CI 0.26 to 1.10) but no clear difference in serious maternal morbidity (RR 1.08, 95% CI 0.89 to 1.32). It reduced the risk of placental abruption (RR 0.64, 95% CI 0.50 to 0.83; NNTB 100, 95% CI 50 to 1000), and increased caesarean section (RR 1.05, 95% CI 1.01 to 1.10). There was no clear difference in stillbirth or neonatal death (RR 1.04, 95% CI 0.93 to 1.15). Side effects, primarily flushing, were more common with magnesium sulphate (24% versus 5%; RR 5.26, 95% CI 4.59 to 6.03; number need to treat for an additional harmful outcome (NNTH) 6, 95% CI 5 to 6).Follow-up was reported by one trial comparing magnesium sulphate with placebo: for 3375 women there was no clear difference in death (RR 1.79, 95% CI 0.71 to 4.53) or morbidity potentially related to pre-eclampsia (RR 0.84, 95% CI 0.55 to 1.26) (median follow-up 26 months); for 3283 children exposed in utero

Characteristics and outcomes of patients with eclampsia and severe pre-eclampsia in a rural hospital in Western Tanzania : a retrospective medical record study

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Mooij, Rob; Lugumila, Joseph; Mwashambwa, Masumbuko Y.; Mwampagatwa, Ipyana H.; van Dillen, Jeroen; Stekelenburg, Jelle

2015-01-01

Background: Eclampsia and pre-eclampsia are well-recognized causes of maternal and neonatal mortality in low income countries, but are never studied in a district hospital. In order to get reliable data to facilitate the hospital's obstetric audit a retrospective medical record study was performed

Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.

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Hughes, Ruth C E; Rowan, Janet; Williman, Jonathan

2018-03-03

Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. Two tertiary referral centres in New Zealand. Women measured at booking, without pre-existing diabetes. Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. Recruitment rate, adherence to protocol and validation of potential primary outcomes. Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and

The effects of labor and delivery on maternal and neonatal outcomes in term twins: a retrospective cohort study.

Science.gov (United States)

Wenckus, D J; Gao, W; Kominiarek, M A; Wilkins, I

2014-08-01

To compare maternal and neonatal outcomes in twins undergoing a trial of labor versus pre-labor caesarean. Retrospective cohort study. 19 US hospitals from the Consortium on Safe Labor. Of 2225 twin sets ≥36 weeks' gestation. Maternal (abruption, estimated blood loss, postpartum haemorrhage, transfusion, chorioamnionitis, hysterectomy, ICU admission, death) and neonatal outcomes (birth injury, 5-minute Apgar <7, NICU admission, RDS, TTN, sepsis, asphyxia, NICU length of stay, death) were compared between the trial of labour and pre-labour caesarean groups with univariate and multivariate logistic and linear regression analyses. Similar analyses were performed for actual delivery modes. Maternal and neonatal outcomes. Among the 2225 twin sets, 1078 had a trial of labour, and 65.9% of those delivered vaginally. There was an increased risk for postpartum haemorrhage [OR 2.5, 95% confidence interval (CI) 1.4-4.5] and blood transfusion (OR 1.9, 95%CI 1.2-3.2) for the trial of labour compared with pre-labour caesarean groups. Birth injury only occurred in the trial of labour group, 1% Twin A, 0.4% Twin B. Both twins had a higher risk of 5-minute Apgar <7 with trial of labour compared to pre-labour caesarean (A: OR 3.9, 95%CI 1.05-14.5; B: OR 3.9, 95%CI 1.3-12.3). Term twins undergoing a trial of labour have increased maternal haemorrhage and transfusions along with neonatal birth trauma and lower Apgar scores, but these absolute neonatal occurrences were rare. Trial of labour in twins remains a safe and reasonable option in appropriately selected cases. © 2014 Royal College of Obstetricians and Gynaecologists.

Pre-delivery fibrinogen predicts adverse maternal or neonatal outcomes in patients with placental abruption.

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Wang, Liangcheng; Matsunaga, Shigetaka; Mikami, Yukiko; Takai, Yasushi; Terui, Katsuo; Seki, Hiroyuki

2016-07-01

Placental abruption is a severe obstetric complication of pregnancy that can cause disseminated intravascular coagulation and progress to massive post-partum hemorrhage. Coagulation disorder due to extreme consumption of fibrinogen is considered the main pathogenesis of disseminated intravascular coagulation in patients with placental abruption. The present study sought to determine if the pre-delivery fibrinogen level could predict adverse maternal or neonatal outcomes in patients with placental abruption. This retrospective medical chart review was conducted in a center for maternal, fetal, and neonatal medicine in Japan with 61 patients with placental abruption. Fibrinogen levels prior to delivery were collected and evaluated for the prediction of maternal and neonatal outcomes. The main outcome measures for maternal outcomes were disseminated intravascular coagulation and hemorrhage, and the main outcome measures for neonatal outcomes were Apgar score at 5 min, umbilical artery pH, and stillbirth. The receiver-operator curve and multivariate logistic regression analyses indicated that fibrinogen significantly predicted overt disseminated intravascular coagulation and the requirement of ≥6 red blood cell units, ≥10 fresh frozen plasma units, and ≥20 fresh frozen plasma units for transfusion. Moderate hemorrhage occurred in 71.5% of patients with a decrease in fibrinogen levels to 155 mg/dL. Fibrinogen could also predict neonatal outcomes. Umbilical artery pH neonatal outcomes with placental abruption. © 2016 Japan Society of Obstetrics and Gynecology. © 2016 Japan Society of Obstetrics and Gynecology.

A cross-sectional study to evaluate the cranial magnetic resonance imaging findings in eclampsia and severe pre-eclampsia patients and its clinical correlation

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Ruchi Saxena

2018-01-01

Full Text Available Background: Pre-eclampsia/eclampsia remains a high contributor towards maternal mortality and morbidity and also the poor perinatal outcome. Thus, timely prediction of the onset of eclampsia and starting appropriate treatment as early as possible is important for favourable maternal and perinatal outcome. However, there is a dearth of studies, especially in the Indian scenario which correlates the severity of pre-eclampsia/eclampsia and the cranial magnetic resonance imaging (MRI findings, therefore, this study was planned to fill the lacuna. Material and Methods: A total of forty patients admitted in the department, of forty, twenty patients were diagnosed with eclampsia and twenty patients with severe pre-eclampsia. MRI was performed in all these 40 patients and they were divided into two groups. Group I (MRI findings positive n = 17 and Group II (MRI findings negative n = 23, the patients once had agreed to (with consent were sent to MRI centre for MRI to be performed. All the data required along with the patients' sign and symptom were recorded in the pro foma designed for this study. Results: The difference in the study groups was statistically significant regarding headache, seizures, depression of consciousness and visual disorder (P = 0.0085, <0.0001, <0.0001, and <0.0001, respectively. In MRI positive findings patients, the occipital cortex was involved in 100% of patients, parietal cortex in 58.82%, frontal cortex in 58.82% and temporal cortex in only 11.77% of patients. Basal ganglia had an infarct in 11.77%. Conclusion: We have observed patients suffering from severe pre-eclampsia and having positive cerebral findings on MRI scan, However employing MRI for screening is not cost-effective and large-scale randomised control trials are needed to further confirm the role of MRI in severe pre-eclampsia.

Effect of raised serum uric acid level on perinatal and maternal outcome in cases of pregnancy-induced hypertension

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Qumrun Nassa Ahmed

2017-05-01

Full Text Available The aim of this study was to find out the effects of raised serum uric acid level on perinatal and maternal outcome in cases of pregnancy-induced hypertension. One hundred pregnant women with gestational period beyond 28 weeks with pregnancy-induced hypertension-preeclampsia and eclampsia were included in this study and divided into two groups. Group A (n=65 patients with a serum uric acid level >6 mg/dL was compared to Group B (n=35 patients with a uric acid level <6 gm/dL. It revealed that high uric acid level in patients with pregnancy-induced hypertension was a risk factor for several maternal complications like postpartum hemorrhage (Group A, 17.4%; Group B, 22.6%, postpartum eclampsia (Group A, 10.1%; Group B, 9.7%, abruptio placentae (Group A, 8.7%; Group B, 6.4%, HELLP syndrome (Group A, 2.9%; Group B, 0% and pulmonary edema (Group A, 4.3%; Group B, 0%. In case of perinatal outcome, the birth weight, intrauterine growth retardation, intrauterine death, stillbirth and neonatal death rate were worse in Group A 1.9 kg, 66.7, 19, 7 and 8% in comparison to Group B, where those were 2.1, 13, 6, 2, and 2% respectively. In conclusion, high uric acid in blood in patient with hypertensive disorders in pregnancy is a risk factor for several maternal complications.

Adverse Maternal and Neonatal Outcomes in Indicated Compared with Spontaneous Preterm Birth in Healthy Nulliparas: A Secondary Analysis of a Randomized Trial.

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Tita, Alan T; Doherty, Lindsay; Roberts, Jim M; Myatt, Leslie; Leveno, Kenneth J; Varner, Michael W; Wapner, Ronald J; Thorp, John M; Mercer, Brian M; Peaceman, Alan; Ramin, Susan M; Carpenter, Marshall W; Iams, Jay; Sciscione, Anthony; Harper, Margaret; Tolosa, Jorge E; Saade, George R; Sorokin, Yoram

2018-06-01

 To compare the risks of adverse maternal and neonatal outcomes associated with spontaneous (SPTB) versus indicated preterm births (IPTB).  A secondary analysis of a multicenter trial of vitamin C and E supplementation in healthy low-risk nulliparous women. Outcomes were compared between women with SPTB (due to spontaneous membrane rupture or labor) and those with IPTB (due to medical or obstetric complications). A primary maternal composite outcome included: death, pulmonary edema, blood transfusion, adult respiratory distress syndrome (RDS), cerebrovascular accident, acute tubular necrosis, disseminated intravascular coagulopathy, or liver rupture. A neonatal composite outcome included: neonatal death, RDS, grades III or IV intraventricular hemorrhage (IVH), sepsis, necrotizing enterocolitis (NEC), or retinopathy of prematurity.  Of 9,867 women, 10.4% ( N  = 1,038) were PTBs; 32.7% ( n  = 340) IPTBs and 67.3% ( n  = 698) SPTBs. Compared with SPTB, the composite maternal outcome was more frequent in IPTB-4.4% versus 0.9% (adjusted odds ratio [aOR], 4.0; 95% confidence interval [CI], 1.4-11.8), as were blood transfusion and prolonged hospital stay (3.2 and 3.7 times, respectively). The frequency of composite neonatal outcome was higher in IPTBs (aOR, 1.8; 95% CI, 1.1-3.0), as were RDS (1.7 times), small for gestational age (SGA) < 5th percentile (7.9 times), and neonatal intensive care unit (NICU) admission (1.8 times).  Adverse maternal and neonatal outcomes were significantly more likely with IPTB than with SPTB. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Evaluation of the effect of high-dose folic acid on endothelial dysfunction in pre-eclamptic patients: A randomized clinical trial

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Mohammad Hashemi

2016-01-01

Full Text Available Background: Pre-eclampsia as a hypertensive disorder of pregnancy complicates up to 5–10% of pregnancies worldwide. Endothelial dysfunction plays an important role in the pathogenesis of pre-eclampsia. In this study, we aim to evaluate the effect of high-dose folic acid on endothelial dysfunction in pre-eclamptic patients. Materials and Methods: In this triple-blinded randomized clinical trial, the enrolled patients were divided randomly into two groups. Folic acid 5.0 mg or placebo was taken daily by oral administration from the initiation of diagnosis until 2 months after delivery by the participants. Every patient's flow-mediated dilation (FMD was evaluated at the beginning of the study and 2 months after delivery with the same experienced operator at the same period of time (3–5 p.m. by high-resolution B-mode ultrasonography. Potential confounding variables were included in the independent samples t-test. t-test or Mann–Whitney U-test was used in the comparison of means between the intervention and placebo groups. To compare FMD in each group, before and after the intervention, paired t-test was used. Results: Mean value of FMD in intervention (9.64 ± 5.57 and control group (9.30 ± 4.25 has no significant difference before the consumption of drugs (P < 0.05. FMD in intervention group (13.72 ± 7.89 significantly increases after daily consumption of 5 mg folic acid in comparison with control group (10.02 ± 4.81 after daily consumption of placebo (P = 0.002. Conclusion: Increased mean of FMD in intervention group shows that this supplement can improve endothelial function and can be significantly affected by maternal blood pressure during pregnancy and some endothelium-dependent disease such as pre-eclampsia and its associated adverse outcomes.

Prevention of congenital malformations and other adverse pregnancy outcomes with 4.0 mg of folic acid: community-based randomized clinical trial in Italy and the Netherlands

Science.gov (United States)

2014-01-01

Background In 2010 a Cochrane review confirmed that folic acid (FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all congenital malformations (CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on the prevention of prematurity, foetal growth retardation and pre-eclampsia are unclear. Although the most common recommendation is to take 0.4 mg/day, the problem of the most appropriate dose of FA is still open. The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs. Other aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae. Methods/Design This project is a joint effort by research groups in Italy and the Netherlands. Women of childbearing age, who intend to become pregnant within 12 months are eligible for the studies. Women are randomly assigned to receive 4 mg of FA (treatment in study) or 0.4 mg of FA (referent treatment) daily. Information on pregnancy outcomes are derived from women-and-physician information. We foresee to analyze the data considering all the adverse outcomes of pregnancy taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying outcomes separately is large, this project also promotes an international prospective meta-analysis. Discussion The rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of

Hypertensive crisis during pregnancy and postpartum period.

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Too, Gloria T; Hill, James B

2013-08-01

Hypertension affects 10% of pregnancies, many with underlying chronic hypertension, and approximately 1-2% will undergo a hypertensive crisis at some point during their lives. Hypertensive crisis includes hypertensive urgency and emergency; the American College of Obstetricians and Gynecologists describes a hypertensive emergency in pregnancy as persistent (lasting 15 min or more), acute-onset, severe hypertension, defined as systolic BP greater than 160 mmHg or diastolic BP >110 mmHg in the setting of pre-eclampsia or eclampsia. Pregnancy may be complicated by hypertensive crisis, with lower blood pressure threshold for end-organ damage than non-pregnant patients. Maternal assessment should include a thorough history. Fetal assessment should include heart rate tracing, ultrasound for growth and amniotic assessment, and Doppler evaluation if growth restriction is suspected. Initial management of hypertensive emergency (systolic BP >160 mmHg or diastolic BP >110 mmHg in the setting of pre-eclampsia or eclampsia) generally includes the rapid reduction of blood pressure through the use of intravenous antihypertensive medications, with goal systolic blood pressure between 140 mmHg and 150 mmHg and diastolic pressure between 90 mmHg and 100 mmHg. First-line intravenous drugs include labetalol and hydralazine, but other agents may be used, including esmolol, nicardipine, nifedipine, and, as a last resort, sodium nitroprusside. Among patients with hypertensive urgency, slower blood pressure reduction can be provided with oral agents. The objective of this article is to review the current understanding, diagnosis, and management of hypertensive crisis during pregnancy and the postpartum period. Copyright © 2013 Elsevier Inc. All rights reserved.

Salinity in Drinking Water and the Risk of (Pre)Eclampsia and Gestational Hypertension in Coastal Bangladesh: A Case-Control Study

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Khan, Aneire Ehmar; Scheelbeek, Pauline Franka Denise; Shilpi, Asma Begum; Chan, Queenie; Mojumder, Sontosh Kumar; Rahman, Atiq; Haines, Andy; Vineis, Paolo

2014-01-01

Background Hypertensive disorders in pregnancy are among the leading causes of maternal and perinatal death in low-income countries, but the aetiology remains unclear. We investigated the relationship between salinity in drinking water and the risk of (pre)eclampsia and gestational hypertension in a coastal community. Methods A population-based case-control study was conducted in Dacope, Bangladesh among 202 pregnant women with (pre)eclampsia or gestational hypertension, enrolled from the community served by the Upazilla Health Complex, Dacope and 1,006 matched controls from the same area. Epidemiological and clinical data were obtained from all participants. Urinary sodium and sodium levels in drinking water were measured. Logistic regression was used to calculate odds ratios, and 95% confidence intervals. Findings Drinking water sources had exceptionally high sodium levels (mean 516.6 mg/L, S.D 524.2). Women consuming tube-well (groundwater) were at a higher disease risk than rainwater users (psodium concentrations (300.01–600 mg/L, 600.1–900 mg/L, >900.01 mg/L, compared to <300 mg/L) in drinking water (ORs 3.30 [95% CI 2.00–5.51], 4.40 [2.70–7.25] and 5.48 [3.30–9.11] (p-trend<0.001). Significant associations were seen for both (pre)eclampsia and gestational hypertension separately. Interpretation Salinity in drinking water is associated with increased risk of (pre)eclampsia and gestational hypertension in this population. Given that coastal populations in countries such as Bangladesh are confronted with high salinity exposure, which is predicted to further increase as a result of sea level rise and other environmental influences, it is imperative to develop and evaluate affordable approaches to providing water with low salt content. PMID:25268785

The favorable effects of garlic intake on metabolic profiles, hs-CRP, biomarkers of oxidative stress and pregnancy outcomes in pregnant women at risk for pre-eclampsia: randomized, double-blind, placebo-controlled trial.

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Aalami-Harandi, Rezvan; Karamali, Maryam; Asemi, Zatollah

2015-01-01

This study was performed to determine the favorable effects of garlic on metabolic status and pregnancy outcomes among pregnant women at risk for pre-eclampsia. This randomized, double-blind, placebo-controlled trial was conducted among 44 pregnant women, primigravida, aged 18-40 years old at 27 weeks' gestation with positive roll-over test. Participants were randomly assigned to receive either one garlic tablet (equal to 400 mg garlic and 1 mg allicin) (n = 22) or placebo (n = 22) once daily for 9 weeks. Fasting blood samples were taken at baseline and after 9 weeks' intervention to measure metabolic profiles and biomarkers of oxidative stress. Administration of garlic compared with the placebo resulted in decreased levels of serum high sensitivity C-reactive protein (hs-CRP) (-1425.90 versus 1360.50 ng/mL, p = 0.01) and increased plasma glutathione (GSH) (+98.10 versus. -49.87 µmol/l, p = 0.03). A trend toward a significant effect of garlic intake on reducing fasting plasma glucose (FPG) (p = 0.07), insulin (p = 0.09) and increasing quantitative insulin sensitivity check (QUICKI) (p = 0.05) was also observed. Consumption of garlic for 9 weeks among pregnant women at risk for pre-eclampsia led to decreased hs-CRP and increased GSH, but did not affect lipid profiles, total antioxidant capacity (TAC) and pregnancy outcomes.

Perinatal Outcome in Patients With Pre-Eclampsia in Benin City ...

African Journals Online (AJOL)

Objective: To determine the prevalence of pre-eclampsia and examine its influence on perinatal outcome among Nigerian women. Methods: Among 3780 deliveries over a two-and-half year period, 212 singleton infants were born after preeclamptic pregnancies. We compared the perinatal outcome with those of 636 control ...

Salinity in drinking water and the risk of (pre)eclampsia and gestational hypertension in coastal Bangladesh: a case-control study.

Science.gov (United States)

Khan, Aneire Ehmar; Scheelbeek, Pauline Franka Denise; Shilpi, Asma Begum; Chan, Queenie; Mojumder, Sontosh Kumar; Rahman, Atiq; Haines, Andy; Vineis, Paolo

2014-01-01

Hypertensive disorders in pregnancy are among the leading causes of maternal and perinatal death in low-income countries, but the aetiology remains unclear. We investigated the relationship between salinity in drinking water and the risk of (pre)eclampsia and gestational hypertension in a coastal community. A population-based case-control study was conducted in Dacope, Bangladesh among 202 pregnant women with (pre)eclampsia or gestational hypertension, enrolled from the community served by the Upazilla Health Complex, Dacope and 1,006 matched controls from the same area. Epidemiological and clinical data were obtained from all participants. Urinary sodium and sodium levels in drinking water were measured. Logistic regression was used to calculate odds ratios, and 95% confidence intervals. Drinking water sources had exceptionally high sodium levels (mean 516.6 mg/L, S.D 524.2). Women consuming tube-well (groundwater) were at a higher disease risk than rainwater users (p900.01 mg/L, compared to water (ORs 3.30 [95% CI 2.00-5.51], 4.40 [2.70-7.25] and 5.48 [3.30-9.11] (p-trendwater is associated with increased risk of (pre)eclampsia and gestational hypertension in this population. Given that coastal populations in countries such as Bangladesh are confronted with high salinity exposure, which is predicted to further increase as a result of sea level rise and other environmental influences, it is imperative to develop and evaluate affordable approaches to providing water with low salt content.

Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial.

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Sudfeld, Christopher R; Manji, Karim P; Duggan, Christopher P; Aboud, Said; Muhihi, Alfa; Sando, David M; Al-Beity, Fadhlun M Alwy; Wang, Molin; Fawzi, Wafaie W

2017-09-04

Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D 3 supplementation may improve the health of HIV-infected pregnant women and their children. The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D 3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12-27 weeks gestation are randomized to either: 1) 3000 IU vitamin D 3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes. The ToV5 will provide causal evidence on the effect of vitamin D 3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach. ClinicalTrials.gov identifier: NCT02305927

Periodontal disease and pre-eclampsia: a systematic review.

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Kunnen, Alina; van Doormaal, Jasper J; Abbas, Frank; Aarnoudse, Jan G; van Pampus, Maria G; Faas, Marijke M

2010-12-01

This review evaluates the possible relationship between periodontal disease and pre-eclampsia, a major pregnancy complication. A generalized inflammatory response plays an important role in the pathogenesis of pre-eclampsia. Because periodontal disease is a low-grade inflammatory state, periodontal disease might contribute to the pathogenesis of pre-eclampsia. A literature search of PubMed, EMBASE and CINAHL until August 2010 revealed 12 eligible observational studies and three randomized-controlled trials (RCTs). It appeared difficult to compare these studies, due to variations in definitions of periodontal disease and pre-eclampsia, timing of periodontal examination and inadequate control for confounding factors. Eight observational studies reported a positive association, while four studies found no association. None of the RTCs reported reductions in pre-eclamptic rate after periodontal therapy during pregnancy. Therefore, it is questionable whether periodontal disease plays a causal role in the pathogenesis of pre-eclampsia. The observed association in eight observational studies might be the result of induction of periodontal disease due to the pre-eclamptic state or it may be an epiphenomenon of an exaggerated inflammatory response to pregnancy. Larger RCTs with pre-eclampsia as the primary outcome and pathophysiological studies are required to explore causality and to dissect biological mechanisms involved. © 2010 John Wiley & Sons A/S.

Subjective and objective outcomes in randomized clinical trials

DEFF Research Database (Denmark)

Moustgaard, Helene; Bello, Segun; Miller, Franklin G

2014-01-01

explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

A randomized controlled trial of pre-conception treatment for periodontal disease to improve periodontal status during pregnancy and birth outcomes

OpenAIRE

Jiang, Hong; Xiong, Xu; Su, Yi; Zhang, Yiming; Wu, Hongqiao; Jiang, Zhijun; Qian, Xu

2013-01-01

Background Evidence has suggested that periodontal disease is associated with an increased risk of various adverse pregnancy and birth outcomes. However, several large clinical randomized controlled trials failed to demonstrate periodontal therapy during pregnancy reduced the incidence of adverse pregnancy and birth outcomes. It has been suggested that the pre-conception period may be an optimal period for periodontal disease treatment rather than during pregnancy. To date, no randomized cont...

Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health

Science.gov (United States)

2014-01-01

The statistics related to pregnancy and its outcomes are staggering: annually, an estimated 250000-280000 women die during childbirth. Unfortunately, a large number of women receive little or no care during or before pregnancy. At a period of critical vulnerability, interventions can be effectively delivered to improve the health of women and their newborns and also to make their pregnancy safe. This paper reviews the interventions that are most effective during preconception and pregnancy period and synergistically improve maternal and neonatal outcomes. Among pre-pregnancy interventions, family planning and advocating pregnancies at appropriate intervals; prevention and management of sexually transmitted infections including HIV; and peri-conceptual folic-acid supplementation have shown significant impact on reducing maternal and neonatal morbidity and mortality. During pregnancy, interventions including antenatal care visit model; iron and folic acid supplementation; tetanus Immunisation; prevention and management of malaria; prevention and management of HIV and PMTCT; calcium for hypertension; anti-Platelet agents (low dose aspirin) for prevention of Pre-eclampsia; anti-hypertensives for treating severe hypertension; management of pregnancy-induced hypertension/eclampsia; external cephalic version for breech presentation at term (>36 weeks); management of preterm, premature rupture of membranes; management of unintended pregnancy; and home visits for women and children across the continuum of care have shown maximum impact on reducing the burden of maternal and newborn morbidity and mortality. All of the interventions summarized in this paper have the potential to improve maternal mortality rates and also contribute to better health care practices during preconception and periconception period. PMID:25178042

Eclampsia: Feto-Maternal Outcomes in A Tertiary Care Centre in Eastern Nepal

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Sita Ghimire

2016-03-01

Conclusions: Although the obstetric care facilities are improving with time, the feto-maternal outcomes are still poor in our country. Therefore early recognition and proper management are vital to tackle this challenge. Keywords: eclampsia; fetomaternal outcomes; retrospective analysis. | PubMed

Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study.

Science.gov (United States)

Roberts, D; Vause, S; Martin, W; Green, P; Walkinshaw, S; Bricker, L; Beardsmore, C; Shaw, N; McKay, A; Skotny, G; Williamson, P; Alfirevic, Z

2014-05-01

To assess short- and long-term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. This was a prospective non-blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention-to-treat analysis was used. The study was conducted in four UK hospital-based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was amnioinfusion and 28 to expectant management) recruited between 2002 and 2009. There was no significant difference in perinatal mortality (19/28 vs 19/28; relative risk (RR) 1.0 (95% CI, 0.70-1.43)) and maternal or neonatal morbidity. The overall chance of surviving without long-term respiratory or neurodevelopmental disability was 4/56 (7.1%); 4/28 (14.3%) in the amnioinfusion group and 0/28 in the expectant group (RR 9.0 (95% CI, 0.51-159.70)). This pilot study found no major differences in maternal, perinatal or pregnancy outcomes. The study was not designed to show a difference between the groups and the number of survivors was too small to draw any conclusions about long-term outcomes. It does, however, signal that a larger definitive study to evaluate amnioinfusion for improvement in healthy

Maternal Preeclampsia and Neonatal Outcomes

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Carl H. Backes

2011-01-01

Full Text Available Preeclampsia is a multiorgan, heterogeneous disorder of pregnancy associated with significant maternal and neonatal morbidity and mortality. Optimal strategies in the care of the women with preeclampsia have not been fully elucidated, leaving physicians with incomplete data to guide their clinical decision making. Because preeclampsia is a progressive disorder, in some circumstances, delivery is needed to halt the progression to the benefit of the mother and fetus. However, the need for premature delivery has adverse effects on important neonatal outcomes not limited to the most premature infants. Late-preterm infants account for approximately two thirds of all preterm deliveries and are at significant risk for morbidity and mortality. Reviewed is the current literature in the diagnosis and obstetrical management of preeclampsia, the outcomes of late-preterm infants, and potential strategies to optimize fetal outcomes in pregnancies complicated by preeclampsia.

Diet and Pre-eclampsia: A Prospective Multicentre Case-Control Study in Ethiopia.

Science.gov (United States)

Endeshaw, Mulualem; Abebe, Fantu; Bedimo, Melkamu; Asart, Anemaw

2015-06-01

Pre-eclampsia is one of the most commonly encountered hypertensive disorders of pregnancy that accounts for 20-80% of maternal mortality in developing countries, including Ethiopia. For many years, diet has been suggested to play a role in pre-eclampsia. However, the hypotheses have been diverse with inconsistent results across studies, and this has not been studied in Ethiopia. The objective of this study was to determine the effect of dietary habits on the incidence of pre-eclampsia in Bahir Dar, Ethiopia A prospective multicentre unmatched case-control study was conducted among 453 (151 cases and 302 controls) pregnant women attending antepartum or intrapartum care in public health facilities of Bahir Dar City from June to September 2014. The interviewer conducted a face-to-face interview, measured the mid-upper arm circumference (MUAC) and collected the mid-pregnancy haemoglobin level from clinical notes using a standardized and pretested questionnaire. Epi Info 3.5.3 was used for data entry and cleaning, while IBM SPSS Statistics 20 was used for data analysis. Backward stepwise unconditional logistic regression analysis was employed to determine the strength of association of predictive variables with the outcome variable and to control for the effect of confounding variables. A P-value ≤0.05 was considered statistically significant. For every 1-cm increase of MUAC, there was an increase in the incidence rate of pre-eclampsia by a factor of 1.35 (adjusted odds ratio (AOR)=1.35, 95% confidence interval (CI): 1.21, 1.51). A higher incidence of pre-eclampsia was found in women who reported to have consumed coffee daily during pregnancy (AOR=1.78, 95% CI: 1.20, 3.05). Similarly, for women who had anaemia during the first trimester, the incidence of pre-eclampsia was 2.5 times higher than their counterparts (AOR=2.47, 95% CI: 1.12, 7.61). This study also revealed consumption of fruit or vegetables at least three times a week during pregnancy to be protective

Can adverse maternal and perinatal outcomes be predicted when blood pressure becomes elevated? Secondary analyses from the CHIPS (Control of Hypertension In Pregnancy Study) randomized controlled trial

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Magee, Laura A.; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Gruslin, Andrée; Helewa, Michael; Hutton, Eileen; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean Marie

2016-01-01

Introduction. For women with chronic or gestational hypertension in CHIPS (Control of Hypertension In Pregnancy Study, NCT01192412), we aimed to examine whether clinical predictors collected at randomization could predict adverse outcomes. Material and methods. This was a planned, secondary analysis

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

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Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Background rates of adverse pregnancy outcomes for assessing the safety of maternal vaccine trials in sub-Saharan Africa.

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Lauren A V Orenstein

Full Text Available Maternal immunization has gained traction as a strategy to diminish maternal and young infant mortality attributable to infectious diseases. Background rates of adverse pregnancy outcomes are crucial to interpret results of clinical trials in Sub-Saharan Africa.We developed a mathematical model that calculates a clinical trial's expected number of neonatal and maternal deaths at an interim safety assessment based on the person-time observed during different risk windows. This model was compared to crude multiplication of the maternal mortality ratio and neonatal mortality rate by the number of live births. Systematic reviews of severe acute maternal morbidity (SAMM, low birth weight (LBW, prematurity, and major congenital malformations (MCM in Sub-Saharan African countries were also performed.Accounting for the person-time observed during different risk periods yields lower, more conservative estimates of expected maternal and neonatal deaths, particularly at an interim safety evaluation soon after a large number of deliveries. Median incidence of SAMM in 16 reports was 40.7 (IQR: 10.6-73.3 per 1,000 total births, and the most common causes were hemorrhage (34%, dystocia (22%, and severe hypertensive disorders of pregnancy (22%. Proportions of liveborn infants who were LBW (median 13.3%, IQR: 9.9-16.4 or premature (median 15.4%, IQR: 10.6-19.1 were similar across geographic region, study design, and institutional setting. The median incidence of MCM per 1,000 live births was 14.4 (IQR: 5.5-17.6, with the musculoskeletal system comprising 30%.Some clinical trials assessing whether maternal immunization can improve pregnancy and young infant outcomes in the developing world have made ethics-based decisions not to use a pure placebo control. Consequently, reliable background rates of adverse pregnancy outcomes are necessary to distinguish between vaccine benefits and safety concerns. Local studies that quantify population-based background rates of

Chronic hypertension and the risk for adverse pregnancy outcome after superimposed pre-eclampsia.

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Vanek, M; Sheiner, E; Levy, A; Mazor, M

2004-07-01

To determine the risk factors and pregnancy outcome of patients with chronic hypertension during pregnancy after controlling for superimposed preeclampsia. A comparison of all singleton term (>36 weeks) deliveries occurring between 1988 and 1999, with and without chronic hypertension, was performed. Stratified analyses, using the Mantel-Haenszel technique, and a multiple logistic regression model were performed to control for confounders. Chronic hypertension complicated 1.6% (n=1807) of all deliveries included in the study (n=113156). Using a multivariable analysis, the following factors were found to be independently associated with chronic hypertension: maternal age >40 years (OR=3.1; 95% CI 2.7-3.6), diabetes mellitus (OR=3.6; 95% CI 3.3-4.1), recurrent abortions (OR=1.5; 95% CI 1.3-1.8), infertility treatment (OR=2.9; 95% CI 2.3-3.7), and previous cesarean delivery (CD; OR=1.8 CI 1.6-2.0). After adjustment for superimposed preeclampsia, using the Mantel-Haenszel technique, pregnancies complicated with chronic hypertension had higher rates of CD (OR=2.7; 95% CI 2.4-3.0), intra uterine growth restriction (OR=1.7; 95% CI 1.3-2.2), perinatal mortality (OR=1.6; 95% CI 1.01-2.6) and post-partum hemorrhage (OR=2.2; 95% CI 1.4-3.7). Chronic hypertension is associated with adverse pregnancy outcome, regardless of superimposed preeclampsia.

Comparison of neonatal outcomes in women with gestational diabetes with moderate hyperglycaemia on metformin or glibenclamide--a randomised controlled trial.

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George, Anne; Mathews, Jiji E; Sam, Dibu; Beck, Manisha; Benjamin, Santosh J; Abraham, Anuja; Antonisamy, Balevendra; Jana, Atanu K; Thomas, Nihal

2015-02-01

Two oral hypoglycaemic agents, metformin and glibenclamide, have been compared with insulin in separate large randomised controlled trials and have been found to be as effective as insulin in gestational diabetes. However, very few trials have compared metformin with glibenclamide. Of 159 South Indian women with fasting glucose ≥5.5 mmol/l and ≤7.2 mmol/l and/or 2-h post-prandial value ≥6.7 mmol/l and ≤13.9 mmol/l after medical nutritional therapy consented to be randomised to receive either glibenclamide or metformin. 80 women received glibenclamide and 79 received metformin. Neonatal outcomes were assessed by neonatologists who were unaware that the mother was part of a study and were recorded by assessors blinded to the medication the mother was given. The primary outcome was a composite of neonatal outcomes namely macrosomia, hypoglycaemia, need for phototherapy, respiratory distress, stillbirth or neonatal death and birth trauma. Secondary outcomes were birthweight, maternal glycaemic control, pregnancy induced hypertension, preterm birth, need for induction of labour, mode of delivery and complications of delivery. Baseline characteristics were similar but for the higher fasting triglyceride levels in women on metformin. The primary outcome was seen in 35% of the glibenclamide group and 18.9% of the metformin group [95% CI 16.1 (2.5, 29.7); P = 0.02]. The difference in outcome related to a higher rate of neonatal hypoglycaemia in the glibenclamide group (12.5%) versus none in the metformin group [95% CI 12.5(5.3, 19.7); P = 0.001]. Secondary outcomes in both groups were similar. In a south Indian population with gestational diabetes, metformin was associated with better neonatal outcomes than glibenclamide. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

A/H1N1 pandemic influenza vaccination: A retrospective evaluation of adverse maternal, fetal and neonatal outcomes in a cohort of pregnant women in Italy.

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Fabiani, Massimo; Bella, Antonino; Rota, Maria C; Clagnan, Elena; Gallo, Tolinda; D'Amato, Maurizio; Pezzotti, Patrizio; Ferrara, Lorenza; Demicheli, Vittorio; Martinelli, Domenico; Prato, Rosa; Rizzo, Caterina

2015-05-05

Although concerns about safety of influenza vaccination during pregnancy have been raised in the past, vaccination of pregnant women was recommended in many countries during the 2009 A/H1N1 pandemic influenza. A retrospective cohort study was conducted to evaluate the risk of adverse maternal, fetal and neonatal outcomes among pregnant women vaccinated with a MF59-adjuvanted A/H1N1 pandemic influenza vaccine. The study was carried out in four Italian regions (Piemonte, Friuli-Venezia-Giulia, Lazio, and Puglia) among 102,077 pregnant women potentially exposed during the second or third trimester of gestation to the vaccination campaign implemented in 2009/2010. Based on data retrieved from the regional administrative databases, the statistical analysis was performed using the Cox proportional-hazards model, adjusting for the propensity score to account for the potential confounding effect due to the socio-demographic characteristics and the clinical and reproductive history of women. A total of 100,332 pregnant women were eligible for the analysis. Of these, 2003 (2.0%) received the A/H1N1 pandemic influenza vaccination during the second or third trimester of gestation. We did not observe any statistically significant association between the A/H1N1 pandemic influenza vaccination and different maternal outcomes (hospital admissions for influenza, pneumonia, hypertension, eclampsia, diabetes, thyroid disease, and anaemia), fetal outcomes (fetal death after the 22nd gestational week) and neonatal outcomes (pre-term birth, low birth weight, low 5-min Apgar score, and congenital malformations). Pre-existing health-risk conditions (hospital admissions and drug prescriptions for specific diseases before the onset of pregnancy) were observed more frequently among vaccinated women, thus suggesting that concomitant chronic conditions increased vaccination uptake. The results of this study add some evidence on the safety of A/H1N1 pandemic influenza vaccination during

The effect of adding a background infusion to patient-controlled epidural labor analgesia on labor, maternal, and neonatal outcomes: a systematic review and meta-analysis.

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Heesen, Michael; Böhmer, Johannes; Klöhr, Sven; Hofmann, Thomas; Rossaint, Rolf; Straube, Sebastian

2015-07-01

Patient-controlled epidural analgesia (PCEA) has gained popularity, but it is still unclear whether adding a background infusion confers any benefit. A systematic literature search in PubMed, Embase, CINAHL, LILACS, CENTRAL, Clinicaltrials.gov, and ISI WOS was performed to identify randomized controlled double-blind trials that compare PCEA-only with PCEA combined with a continuous infusion (PCEA + CI) in parturients. The data were subjected to meta-analyses using the random-effects model. Our primary outcome was the incidence of instrumental vaginal delivery. Secondary outcomes were incidences of spontaneous vaginal and cesarean deliveries, duration of labor, analgesic outcomes, maternal outcomes (visual analog scale scores for pain, maternal satisfaction, nausea, pruritus, hypotension), and neonatal outcomes (Apgar score, umbilical artery pH). We identified 7 trials with a low risk of bias, reporting on 891 parturients, for inclusion in our systematic review. The risk of instrumental vaginal delivery was increased in the PCEA + CI group, risk ratio (RR) 1.66 (95% confidence interval 1.08-2.56, P = 0.02; I = 0%); the RR for cesarean delivery was 0.83 (95% confidence interval 0.61-1.13, I = 0%). The second stage of labor was prolonged (weighted mean difference 12.3 minutes, 95% confidence interval 5.1-19.5 minutes, P = 0.0008; I = 0%) in the PCEA + CI group. Fewer patients in the PCEA + CI group required physician-administered boluses (RR 0.35 [95% confidence interval 0.25-0.47, P neonatal outcomes (Apgar scores analgesia. Further high-quality studies involving a sufficient number of patients are required.

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial

NARCIS (Netherlands)

Koopmans, Corine M.; Bijlenga, Denise; Groen, Henk; Vijgen, Sylvia C. M.; Aarnoudse, Jan G.; Bekedam, Dick J.; van den Berg, Paul P.; de Boer, Karin; Burggraaff, Jan M.; Bloemenkamp, Kitty W. M.; Drogtrop, Addy P.; Franx, Arie; de Groot, Christianne J. M.; Huisjes, Anjoke J. M.; Kwee, Anneke; van Loon, Aren J.; Lub, Annemiek; Papatsonis, Dimitri N. M.; van der Post, Joris A. M.; Roumen, Frans J. M. E.; Scheepers, Hubertina C. J.; Willekes, Christine; Mol, Ben W. J.; van Pampus, Maria G.

2009-01-01

Background Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. Methods

Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT) : a multicentre, open-label randomised controlled trial

NARCIS (Netherlands)

Koopmans, C.M.; Bijlenga, D.; Groen, H.; Vijgen, S.M.C.; Aarnoudse, J.G.; Bekedam, D; van den Berg, P.P.; de Boer, K.; Burggraaff, Jan; Bloemenkamp, K.W.M.; Drogtrop, A.P.; Franx, A.; de Groot, C.J.M.; Huisjes, A.J.M.; Kwee, A.; van Loon, A.J.; Lub, A.; Papatsonis, D.N.M.; van der Post, J.A.M.; Roumen, F.J.M.E.; Scheepers, H.C.J.; Willekes, C.; Mol, B.W.J.; van Pampus, Maria

2009-01-01

Background Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. Methods

Effect of metformin on maternal and neonatal outcomes in pregnant obese non-diabetic women: A meta-analysis

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Ahmed Elmaraezy

2017-09-01

Full Text Available Background: Metformin reduces maternal and neonatal weight gain in gestational diabetes mellitus; however, this effect is poorly investigated in non-diabetic women. Objective: We performed this meta-analysis to investigate the effect of metformin intake during pregnancy on maternal and neonatal outcomes in obese non-diabetic women. Materials and Methods: We searched Medline, EMBASE, and Cochrane CENTRAL for eligible randomized controlled trials addressing the efficacy of metformin in pregnant obese non-diabetic women. Data were extracted and analyzed using RevMan software (Version 5.3. Neonatal birth weight was the key outcome. Secondary outcomes included maternal weight gain, the incidence of preeclampsia, and neonatal adverse effects (miscarriage, stillbirth and congenital anomalies. Results: Pooled data from two RCTs (n=843 showed that metformin caused a significant reduction in maternal gestational weight gain (MD-1.35, 95% CI: [2.08, -0.630], compared to placebo. The summary effect-estimate did not favor either of the two groups in terms of reduction of neonatal birth weight Z score (MD-0.09, 95% CI: [0.23, 0.06]. Metformin was associated with 41% reduction in the risk of preeclampsia; however, this reduction was not statistically significant [RR 0.59, 95% CI: [0.03, 11.46]. None of the neonatal adverse events including stillbirth [RR 1.14, 95% CI: 0.42, 3.10] and congenital anomalies (RR= 1.36, 95% CI: [0.58, 3.21] differed significantly between the two groups. Conclusion: For obese pregnant women, metformin could decrease gestational weight gain with no significant reduction in neonatal birth weight. In light of the current evidence, metformin should not be used to prevent poor pregnancy outcomes in obese non-diabetic women.

Association between gestational weight gain and perinatal outcomes in women with chronic hypertension.

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Yee, Lynn M; Caughey, Aaron B; Cheng, Yvonne W

2017-09-01

Gestational weight gain above or below the 2009 National Academy of Medicine guidelines has been associated with adverse maternal and neonatal outcomes. Although it has been well established that excess gestational weight gain is associated with the development of gestational hypertension and preeclampsia, the relationship between gestational weight gain and adverse perinatal outcomes among women with pregestational (chronic) hypertension is less clear. The objective of this study was to examine the relationship between gestational weight gain above and below National Academy of Medicine guidelines and perinatal outcomes in a large, population-based cohort of women with chronic hypertension. This is a population-based retrospective cohort study of women with chronic hypertension who had term, singleton, vertex births in the United States from 2012 through 2014. Prepregnancy body mass index was calculated using self-reported prepregnancy weight and height. Women were categorized into 4 groups based on gestational weight gain and prepregnancy body mass index: (1) weight gain less than, (2) weight gain within, (3) weight gain 1-19 lb in excess of, and (4) weight gain ≥20 lb in excess of the National Academy of Medicine guidelines. The χ 2 tests and multivariable logistic regression analysis were used for statistical comparisons. Stratified analyses by body mass index category were additionally performed. In this large birth cohort, 101,259 women met criteria for inclusion. Compared to hypertensive women who had gestational weight gain within guidelines, hypertensive women with weight gain ≥20 lb over National Academy of Medicine guidelines were more likely to have eclampsia (adjusted odds ratio, 1.93; 95% confidence interval, 1.54-2.42) and cesarean delivery (adjusted odds ratio, 1.60; 95% confidence interval, 1.50-1.70). Excess weight gain ≥20 lb over National Academy of Medicine guidelines was also associated with increased odds of 5-minute Apgar gain 1-19 lb

Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

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Safura Ruholamin

2014-01-01

Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

Effects of intrapartum epidural analgesia at high altitudes: maternal, fetal, and neonatal outcomes. A randomized controlled trial of two formulations of analgesics.

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Shokry, Mahmoud; Manaa, Essam M; Shoukry, Randa Ali; Shokeir, Mohamed Hossam; Elsedfy, Ghada O; Abd El-Aziz, Abd El-Salam

2010-07-01

To investigate whether intrapartum epidural analgesics (bupivacaine or ropivacaine) have an influence (safety and efficacy) on mothers, fetuses, or newborns at high altitudes (2,200 m above the sea level). Prospective randomized trial. A tertiary referral hospital in Aseer region, Saudi Arabia. Eighty parturient women with normal full term pregnancy (37-40 weeks) were randomly allocated to a group receiving epidural bupivacaine 0.125% and the other receiving ropivacaine 0.2%, with fentanyl 100 microg given to both groups. Intra- and postpartum clinical management of the pregnant women and newborns and fetal Doppler assessments were performed. Severity of pain, onset and duration of analgesia, and occurrence of motor blockade were primary outcomes. Progress of labor, need for oxytocin augmentation, mode of delivery, and neonatal condition were secondary outcomes. Demographic, labor characteristics, and neonatal outcomes of the two groups were comparable. The onset of analgesia was relatively more rapid for ropivacaine group (p = 0.067). Duration of analgesia after the first bolus dose was longer and the need for supplemental epidural analgesic doses was lesser in the bupivacaine group (p = 0.041 and 0.045, respectively). In both groups, the fetal umbilical and middle cerebral artery pulsatility indices showed significant change when compared to the baseline of the same group. At high altitudes, no major advantage was found for epidural ropivacaine over bupivacaine in addition to fentanyl for labor analgesia and no harmful effects of the medications were found on mothers, fetuses, or newborns.

Maternal or neonatal infection: association with neonatal encephalopathy outcomes.

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Jenster, Meike; Bonifacio, Sonia L; Ruel, Theodore; Rogers, Elizabeth E; Tam, Emily W; Partridge, John Colin; Barkovich, Anthony James; Ferriero, Donna M; Glass, Hannah C

2014-07-01

Perinatal infection may potentiate brain injury among children born preterm. The objective of this study was to examine whether maternal and/or neonatal infection are associated with adverse outcomes among term neonates with encephalopathy. This study is a cohort study of 258 term newborns with encephalopathy whose clinical records were examined for signs of maternal infection (chorioamnionitis) and infant infection (sepsis). Multivariate regression was used to assess associations between infection, pattern, and severity of injury on neonatal magnetic resonance imaging, as well as neurodevelopment at 30 mo (neuromotor examination, or Bayley Scales of Infant Development, second edition mental development index encephalopathy, chorioamnionitis was associated with a lower risk of brain injury and adverse outcomes, whereas signs of neonatal sepsis carried an elevated risk. The etiology of encephalopathy and timing of infection and its associated inflammatory response may influence whether infection potentiates or mitigates injury in term newborns.

Maternal haemoglobin and short-term neonatal outcome in preterm neonates.

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Elodie Savajols

Full Text Available To determine whether there is a significant association between maternal haemoglobin measured before delivery and short-term neonatal outcome in very preterm neonates.We included prospectively all live births occurring from 25 to 32+6 weeks of gestation in a tertiary care centre between January 1(st 2009 and December 31(st 2011. Outborn infants and infants presenting with lethal malformations were excluded. Three hundred and thirty-nine mothers and 409 infants met the inclusion criteria. For each mother-infant pair a prospective record of epidemiologic data was performed and maternal haemoglobin concentration recorded within 24 hours before delivery was retrospectively researched. Maternal haemoglobin was divided into quartiles with the second and the third one regarded as reference as they were composed of normal haemoglobin values. Short-term outcome was defined as poor in case of death during hospital stay and/or grades III/IV intraventricular haemorrhage and/or periventricular leukomalacia and/or necessity of ventriculoperitoneal shunt.The global rate of poor short-term neonatal outcome was 11.4% and was significantly associated with low maternal haemoglobin values. This association remained significant after adjustment for antenatal corticosteroids therapy, gestational age, parity, mechanism of preterm birth, mode of delivery and birth weight (aOR = 2.97 CI 95% [1.36-6.47]. There was no relation between short-term neonatal outcome and high maternal haemoglobin concentration values.We show that low maternal haemoglobin concentration at delivery is an independent risk factor for poor short-term neonatal outcome in very preterm neonates. This study is one of the first to show such an association within the preterm population.

Treatment of valvular heart disease during pregnancy for improving maternal and neonatal outcome.

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Henriquez, Dacia Dca; Roos-Hesselink, Jolien W; Schalij, Martin J; Klautz, Robert Jm; Helmerhorst, Frans M; de Groot, Christianne Jm

2011-05-11

Valvular heart disease constitutes the majority of all causes of heart disease in pregnancy. In the presence of valvular heart disease, the necessary haemodynamic changes of pregnancy might cause heart failure, leading to severe maternal and fetal morbidity and even mortality. Treatment of valvular heart disease is indicated when patients experience a deterioration of symptoms and in case of a severe valvular lesion. Whether medical therapy or interventional therapy is the optimal treatment for both mother and child is unclear. To assess effectiveness and adverse effects of the different treatment modalities of valvular heart disease in pregnancy to improve maternal and neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2011), EMBASE (1980 to 23 March 2011) and the reference lists of background review articles. Randomised controlled trials, quasi-randomised controlled and cluster-randomised controlled trials comparing medical therapy with percutaneous or surgical intervention for the treatment of valvular heart disease in pregnancy. We identified no (randomised) controlled trials to assess the effectiveness and adverse effects of the treatment of valvular heart disease in pregnancy. There were no randomised controlled trials, quasi-randomised controlled trials or cluster-randomised trials identified from the search strategy. There is insufficient evidence to define the most effective treatment of valvular heart disease in pregnancy to improve maternal and neonatal outcomes.

Comparison of maternal and newborn outcomes of Tibetan and Han Chinese delivering in Lhasa, Tibet

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Miller, Suellen; Tudor, Carrie; Thorsten, Vanessa; Nyima; Sonam; Droyoung; Wright, Linda; Varner, Michael

2009-01-01

Aim To compare maternal and neonatal outcomes of Tibetan and Han Chinese women delivering vaginally at high altitude (3650 meters) in Lhasa, Tibet Autonomous Region, People’s Republic of China. Method Comparative analysis of data from a prospective observational study of Tibetan (n = 938) and Han Chinese (n = 146) women delivering at three hospitals between January 2004 and May 2005. Results Han Chinese women had higher rates of pre-eclampsia/gestational hypertension than Tibetan women, (10.3% vs 5.9%, P = 0.04). There was no difference in rates of postpartum hemorrhage between Tibetan and Han women (12.8% vs 17.1%, P = 0.15). Han newborns weighed significantly less than Tibetan newborns (P < 0.01), and were twice as likely to be small for gestational age, (24.5% vs 11.6%, P < 0.01). Tibetan newborns were less likely to have poor neonatal outcomes than Han newborns (P < 0.01). Conclusion In high altitude deliveries in Tibet, adverse outcomes were significantly more common among Han Chinese. PMID:19012697

First trimester serum placental growth factor and hyperglycosylated human chorionic gonadotropin are associated with pre-eclampsia: a case control study.

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Keikkala, Elina; Koskinen, Sini; Vuorela, Piia; Laivuori, Hannele; Romppanen, Jarkko; Heinonen, Seppo; Stenman, Ulf-Håkan

2016-11-25

To study whether maternal serum hyperglycosylated human chorionic gonadotropin (hCG-h) improves first trimester prediction of pre-eclampsia when combined with placental growth factor (PlGF), pregnancy-associated plasma protein-A (PAPP-A) and maternal risk factors. Gestational-age-adjusted concentrations of hCG, hCG-h, PlGF and PAPP-A were analysed in serum samples by time-resolved immunofluorometric assays at 8-13 weeks of gestation. The case-control study included 98 women who developed pre-eclampsia, 25 who developed gestational hypertension, 41 normotensive women with small-for-gestational-age (SGA) infants and 177 controls. Of 98 women with pre-eclampsia, 24 women developed preterm pre-eclampsia (diagnosis factors.

Presentation and outcome of eclampsia at a tertiary center in South East Nigeria--a 6-year review.

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Eke, Ahizechukwu Chigoziem; Ezebialu, Ifeanyichukwu Uzoma; Okafor, Charles

2011-01-01

To determine the maternal and fetal outcomes of eclamptic patients treated in Nnamdi Azikiwe University Teaching Hospital, Nnewi, over a 6-year period (2004-2009). It was a retrospective study. The case notes of 212 patients with eclampsia were analyzed with respect to age, parity, type of eclampsia, gestational age, booking status, mode of delivery, and outcome of the babies and mothers. There were 212 cases of eclampsia out of a total of 13,536 deliveries, giving a prevalence of 1.57%. One hundred and sixty (24.5%) of the women were unbooked. Antepartum eclampsia constituted 160 (75.5%) of all types of eclampsia. Nulliparous teenagers were the most commonly affected women--128 (60.4%). Cesarean delivery was higher than vaginal delivery, accounting for 160 (75.5%) of all deliveries. There was a statistically significant relationship between the route of delivery and the parity of the women (χ(2) = 3.60; d = 5; p = 0.035). There were 16 maternal deaths, giving a case fatality rate of 7.5%. There were 12 neonatal and 8 perinatal deaths. Puerperal sepsis occurred in 9.4% of the patients. Eclampsia is a major cause of maternal mortality in Nnewi, rural South East Nigeria. Teenage nulliparous women are most susceptible.

Hypertensive crisis in children: an experience in a single tertiary care center in Korea.

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Lee, Geum Hwa; Lee, I Re; Park, Se Jin; Kim, Ji Hong; Oh, Ji Young; Shin, Jae Il

2015-01-01

Hypertensive crisis is a medical emergency that can cause acute damage to multiple end-organs. However, relatively little is known on the etiology, treatment, and outcomes of hypertensive crisis in Korean children. The aim of this study was to determine the etiologies and efficacy of drugs for hypertensive crisis in children during the past 5 years at a single center in Korea. We analyzed data from 51 children with hypertensive crisis during the period between January 1, 2010 and April 1, 2014. The patients were divided into two groups: those diagnosed with a hypertensive emergency (hypertension with organ injury, n = 31) and those diagnosed with a hypertensive urgency (hypertension without organ injury, n = 20). Baseline etiologies and risk factors were compared between the two groups. In addition, systolic and diastolic blood pressures were evaluated at 1, 2, 4, and 5 hours after the administration of intravenous antihypertensive drugs. Kidney injury and cancer were the common causes in patients with hypertensive crisis. Cardiovascular complications (cardiac hypertrophy) (p = 0.002), central nervous system complications (p = 0.004), and retinopathy (p = 0.034) were more frequently observed in children with hypertensive emergency than those with hypertensive urgency. However, the proportion of renal complications was similar in both groups. Hydralazine was most commonly used in both groups to control acute increasing blood pressure at first. However, it was often ineffective for controlling abrupt elevated blood pressure. Therefore, intravenous antihypertensive drugs were changed from hydralazine to nicardipine, labetalol, or nitroprusside to control the high blood pressure in 45.1 % of the patients. Particularly, in patients with hypertensive crisis, there was no significant difference in reduction of systolic and diastolic blood pressure and in improvement of clinical outcomes between nicardipine and labetalol administration. Close blood

Hypertension in pregnancy

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Andrea Ungar

2007-03-01

Full Text Available Hypertension is the most common medical problem encountered during pregnancy, complicating 2-3% of pregnancies. Hypertensive disorders during pregnancy are classified into 4 categories: chronic hypertension, pre-eclampsia/eclampsia, pre-eclampsia superimposed on chronic hypertension, and gestational hypertension. A relative paucity of investigative data, as well as the frequent difficulty in making an etiological diagnosis, may lead to problems in its management. This case report analyses current concepts regarding the hypertensive disorders of gestation, focusing on chronic hypertension. Chronic hypertension is defined as blood pressure exceeding 140/90 mmHg before pregnancy or before 20 weeks gestation. Hypertensive disorders in pregnancy may cause maternal and fetal morbidity and remain a leading source of maternal mortality. A prompt diagnosis is needed also because hypertension may be an indicator of pre-eclampsia, a condition which can evolve into serious complications. Maintaining blood pressure below 140/90 mmHg is recommended, although treatment should be determined on an individual basis. Many anti-hypertensive agents appear to be safe for use during pregnancy: methildopa has been the most studied of the anti-hypertensive drugs and has the best safety record. Labetalol, idralazine and nifedipine also have been found to be safe; ACE-inhibitors are absolutely contraindicated, because they are associated with intrauterine growth retardation.

The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761

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2004-03-01

Full Text Available Abstract Background The Magpie Trial compared magnesium sulphate with placebo for women with pre-eclampsia. 10,141 women were recruited, 8804 before delivery. Overall, 9024 children were included in the analysis of outcome at discharge from hospital. Magnesium sulphate more than halved the risk of eclampsia, and probably reduced the risk of maternal death. There did not appear to be any substantive harmful effects on the baby, in the short term. It is now important to assess whether these benefits persist, and to provide adequate reassurance about longer term safety. The main objective of the Magpie Trial Follow Up Study is to assess whether in utero exposure to magnesium sulphate has a clinically important effect on the child's chance of surviving without major neurosensory disability. Other objectives are to assess long term outcome for the mother, and to develop and assess appropriate strategies for following up large numbers of children in perinatal trials. Study design Follow up is only feasible in selected centres. We therefore anticipate contacting 2800–3350 families, for 2435–2915 of whom the woman was randomised before delivery. A further 280–335 children would have been eligible for follow up if they had survived. The total sample size for the children is therefore 3080–3685, 2680–3210 of whom will have been born to women randomised before delivery. Families eligible for the follow up will be contacted, and surviving children screened using the Ages and Stages Questionnaires. Children who screen positive, and a sample of those who screen negative, will whenever possible have a paediatric and neurodevelopmental assessment. When women are contacted to ask how their child is, they will also be asked about their own health. The primary outcome is a composite measure of death or neurosensory disability for the child at 18 months. Discussion The Follow Up Study began in 2002, and now involves collaborators in 19 countries. Data

Hypertension in pregnancy: natural history and treatment options.

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Foo, L; Tay, J; Lees, C C; McEniery, C M; Wilkinson, I B

2015-05-01

Hypertensive disorders of pregnancy affect approximately 5-10% of all maternities and are major contributors of maternal and neonatal morbidity and mortality worldwide. This group of disorders encompasses chronic hypertension, as well as conditions that arise de novo in pregnancy: gestational hypertension and pre-eclampsia. The latter group is thought to be part of the same continuum but with arbitrary division. Research into the aetiology of hypertension in pregnancy have largely been focused on pre-eclampsia, with a majority of studies exploring either pregnancy-associated factors such as placental-derived or immunologic responses to pregnancy tissue, or maternal constitutional factors such as cardiovascular health and endothelial dysfunction. The evidence base for the pathophysiology and progression of hypertensive disorders in pregnancy, particularly pre-eclampsia, is reviewed. Clinical algorithms and pharmacological agents for the management of hypertension in pregnancy are summarised, with a brief focus on post-partum considerations and long-term health implications. Novel therapeutic options for the management of pre-eclampsia are also explored.

ANALYSIS OF MATERNAL AND FETAL OUTCOME IN SPINAL VERSUS EPIDURAL ANESTHESIA FOR CESAREAN DELIVERY IN SEVERE PRE-ECLAMPSIA

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Jyothi

2015-12-01

Full Text Available AIM Our primary aim is to analyze of maternal and fetal outcome in spinal versus epidural anesthesia for cesarean delivery in severe pre-eclampsia. MATERIALS AND METHODS Sixty parturients (60 with severe pre-eclampsia posted for cesarean section were randomized into two groups of thirty (30 each for either spinal anesthesia that is group S or epidural anesthesia that is group E. Spinal group (group S, n=30 received 10mg (2ml of 0.5% of hyperbaric bupivacaine solution intrathecally in left lateral decubitus or sitting position at L3-4 lumbar space with 25G quincke-babcock spinal needle. Patients received 6l/min of oxygen through Hudson’s face mask throughout the surgery. In Epidural group (group E, n=30, after thorough aseptic precautions, an 18G Tuohy’s epidural needle inserted at the L3-4 lumbar space with the patient in lateral decubitus or sitting position. Three ml of 1.5% lidocaine with was given as a test dose. After ruling out any intrathecal injection of the drug, initially 8ml of 0.5% isobaric bupivacaine given and the vitals monitored. Then 3ml top-ups of the same bupivacaine solution is given in a graded manner slowly, simultaneously checking the height of block. A blockade upto T4 to T6 is required. Vitals are carefully monitored and oxygen is provided 6l/min throughout the procedure and surgery. Blood pressure (systolic, mean, diastolic, pulse rate, oxygen saturation are recorded immediately after giving anesthesia, every minute for first 10mins, then every 3mins for the rest of the surgery. Then vitals are also noted post-operatively for the first 24hrs. Apgar score after 1 and 5 minutes, of the newborn baby is also recorded. Other parameters noted were incidence and duration of hypotension or hypertension both intra-operatively and post-operatively, any usage of vasopressors (ephedrine and its dose, convulsions, renal failure, pulmonary edema, requirement for ICU stay and the number of days in the mother, and the incidence of

The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial.

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Miremberg, Hadas; Ben-Ari, Tal; Betzer, Tal; Raphaeli, Hagit; Gasnier, Rose; Barda, Giulia; Bar, Jacob; Weiner, Eran

2018-04-01

Patient compliance and tight glycemic control have been demonstrated to improve outcome in pregnancies complicated by gestational diabetes mellitus. The use of advanced technological tools, including smartphone-based platforms, to improve medical care and outcomes has been demonstrated in various fields of medicine, but only a few small studies were performed with gestational diabetes mellitus patients. We aimed to study the impact of introducing a smartphone-based daily feedback and communication platform between gestational diabetes mellitus patients and their physicians, on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction. This is a prospective, single-center, randomized controlled trial. Newly diagnosed gestational diabetes mellitus patients presenting to our multidisciplinary diabetes-in-pregnancy clinic were randomized to: (1) routine biweekly prenatal clinic care (control group); or (2) additional daily detailed feedback on their compliance and glycemic control from the clinic team via an application installed on their smartphone (smartphone group). The primary outcome was patient compliance defined as the actual blood glucose measurements/instructed measurements ×100. The secondary outcomes included diabetes-control parameters, pregnancy, and neonatal outcomes. The study was adequately powered to detect a 20% difference in patient compliance, based on a preliminary phase that demonstrated 70% baseline compliance to glucose measurements. A total of 120 newly diagnosed gestational diabetes mellitus patients were analyzed. The 2 groups did not differ in terms of age, parity, education, body mass index, family history, maternal comorbidities, oral glucose tolerance test values, and hemoglobin A1C at randomization. The smartphone group demonstrated higher level of compliance (84 ± 0.16% vs 66 ± 0.28%, P diabetes mellitus patients and the multidisciplinary diabetes-in-pregnancy clinic team improved patient compliance and

The impact of a new standard labor protocol on maternal and neonatal outcomes.

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Wang, Dingran; Ye, Shenglong; Tao, Liyuan; Wang, Yongqing

2017-12-01

To analyze the clinical outcomes following the implementation of a new standard labor procedure. This was a retrospective analysis that included a study group consisting of patients managed based on a new standard labor protocol and a control group comprising patients managed under an old standard labor protocol. The following maternal and perinatal outcomes were compared in the two groups: the indications for a cesarean section and the incidence of cesarean section, postpartum hemorrhage, fetal distress, neonatal asphyxia and pediatric intervention. We also compared the average number of days spent in the hospital, the incidence of medical disputes and hospitalization expenses. The cesarean section rates for the study and control groups were 19.29% (401/2079) and 33.53% (753/2246), respectively (P labor, fetal distress and intrapartum fever; the percentages of each indication were significantly different from those of the control group (P labor protocol reduced the cesarean section rate without negatively impacting maternal and neonatal outcomes. In practice, bed turnover and the hospital utilization rate should be better controlled, patient-doctor communication should be strengthened and the quality of obstetrical service should be improved.

Vaginal birth after cesarean: new insights on maternal and neonatal outcomes.

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Guise, Jeanne-Marie; Denman, Mary Anna; Emeis, Cathy; Marshall, Nicole; Walker, Miranda; Fu, Rongwei; Janik, Rosalind; Nygren, Peggy; Eden, Karen B; McDonagh, Marian

2010-06-01

To systematically review the evidence about maternal and neonatal outcomes relating to vaginal birth after cesarean (VBAC). Relevant studies were identified from multiple searches of MEDLINE, DARE, and the Cochrane databases (1980 to September 2009) and from recent systematic reviews, reference lists, reviews, editorials, Web sites, and experts. Inclusion criteria limited studies to the English-language and human studies conducted in the United States and developed countries specifically evaluating birth after previous cesarean delivery. Studies focusing on high-risk maternal or neonatal conditions, including breech vaginal delivery, or fewer than 10 patients were excluded. Poor-quality studies were not included in analyses. We identified 3,134 citations and reviewed 963 articles for inclusion; 203 articles met the inclusion criteria and were quality rated. Overall rates of maternal harms were low for both trial of labor and elective repeat cesarean delivery. Although rare in both elective repeat cesarean delivery and trial of labor, maternal mortality was significantly increased for elective repeat cesarean delivery at 0.013% compared with 0.004% for trial of labor. The rates of maternal hysterectomy, hemorrhage, and transfusions did not differ significantly between trial of labor and elective repeat cesarean delivery. The rate of uterine rupture for all women with prior cesarean was 0.30%, and the risk was significantly increased for trial of labor (0.47% compared with 0.03% for elective repeat cesarean delivery). Perinatal mortality was also significantly increased for trial of labor (0.13% compared with 0.05% for elective repeat cesarean delivery). Overall the best evidence suggests that VBAC is a reasonable choice for the majority of women. Adverse outcomes were rare for both elective repeat cesarean delivery and trial of labor. Definitive studies are lacking to identify patients who are at greatest risk for adverse outcomes.

Use of outcome measures in pulmonary hypertension clinical trials.

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Parikh, Kishan S; Rajagopal, Sudarshan; Arges, Kristine; Ahmad, Tariq; Sivak, Joseph; Kaul, Prashant; Shah, Svati H; Tapson, Victor; Velazquez, Eric J; Douglas, Pamela S; Samad, Zainab

2015-09-01

To evaluate the use of surrogate measures in pulmonary hypertension (PH) clinical trials and how it relates to clinical practice. Studies of pulmonary arterial hypertension (PAH) employ a variety of surrogate measures in addition to clinical events because of a small patient population, participant burden, and costs. The use of these measures in PH drug trials is poorly defined. We searched PubMed/MEDLINE/Embase for randomized or prospective cohort PAH clinical treatment trials from 1985 to 2013. Extracted data included intervention, trial duration, study design, patient characteristics, and primary and secondary outcome measures. To compare with clinical practice, we assessed the use of surrogate measures in a clinical sample of patients on PH medications at Duke University Medical Center between 2003 and 2014. Between 1985 and 2013, 126 PAH trials were identified and analyzed. Surrogate measures served as primary endpoints in 119 trials (94.0%). Inclusion of invasive hemodynamics decreased over time (78.6%, 75.0%, 52.2%; P for trend = .02), while functional testing (7.1%, 60.0%, 81.5%; P for trend clinical assessments regularly incorporated serial echocardiography and 6-minute walk distance tests (92% and 95% of patients, respectively) and repeat measurement of invasive hemodynamics (46% of patients). The majority of PAH trials have utilized surrogate measures as primary endpoints. The use of these surrogate endpoints has evolved significantly over time with increasing use of patient-centered endpoints and decreasing or stable use of imaging and invasive measures. In contrast, imaging and invasive measures are commonly used in contemporary clinical practice. Further research is needed to validate and standardize currently used measures. Copyright © 2015 Elsevier Inc. All rights reserved.

Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China.

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Zhang, Yuting; Tang, Wenxi; Zhang, Yan; Liu, Lulu; Zhang, Liang

2017-03-11

Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. A clustered randomized controlled trial was conducted in six towns in China's Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization's International Clinical Trials Registry, number ChiCTR-OOR-14005563. We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063-3.8), improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094-0.24). We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73-2.79) and reduced rates of hospitalization and inpatient spending, but it also reduced patients' self-assessed health-related quality of life. Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563) on November 23, 2014

Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China

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Yuting Zhang

2017-03-01

Full Text Available Abstract Background Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. Methods A clustered randomized controlled trial was conducted in six towns in China’s Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization’s International Clinical Trials Registry, number ChiCTR-OOR-14005563. Results We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063–3.8, improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094–0.24. We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73–2.79 and reduced rates of hospitalization and inpatient spending, but it also reduced patients’ self-assessed health-related quality of life. Conclusions Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at

Serum 8-isoprostane increased in pre-eclampsia

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Besari Adi Pramono

2012-04-01

Full Text Available Background The main causes of maternal mortality in Indonesia are pre-eclampsia, hemorrhage, and infection. Oxidative stress has a primary role in pre-eclampsia and one of its parameters is 8-isoprostane serum level. The objective of this study is to measure 8-isoprostane and to analyze the relationship between 8-isoprostane level and birth weight in pre-eclampsia. Methods A cross-sectional study involving 23 pre-eclampsia and 29 normotensive pregnant women with normal or cesarean delivery at Dr. Kariadi Hospital Semarang from January to May 2011. Collected maternal blood samples were assessed for 8-Isoprostane levels by means of a specific ELISA kit. Neonatal birth weight was measured immediately after delivery by means of calibrated baby scales. Differences in 8-isoprostane levels between pre-eclampsia and normotensive women were assessed using independent t-test for normal distributed data, and the Mann-Whitney test for non-normally distributed data. Results Mean 8-isoprostane level was significantly higher in women with pre-eclampsia than in normotensive women (62.52 ± 12.19 pg/mL vs 28.64 ± 8.81 pg/mL (p<0.05. Low birth weight was twice as frequent in pre-eclampsia than in normotensives. There was no correlation between 8-isoprostane serum level and neonatal birth weight in pre-eclampsia. Conclusion The level of 8-isoprostane was higher in pre-eclampsia than in normotensives. It is recommended to conduct further studies to determine whether 8-isoprostane may be used as a predictive marker of pre-eclampsia.

Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

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Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2013-09-01

Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

Home blood-pressure monitoring in a hypertensive pregnant population.

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Perry, H; Sheehan, E; Thilaganathan, B; Khalil, A

2018-04-01

The majority of patients with chronic or gestational hypertension do not develop pre-eclampsia. Home blood-pressure monitoring (HBPM) has the potential to offer a more accurate and acceptable means of monitoring hypertensive patients during pregnancy compared with traditional pathways of frequent outpatient monitoring. The aim of this study was to determine whether HBPM reduces visits to antenatal services and is safe in pregnancy. This was a case-control study of 166 hypertensive pregnant women, which took place at St George's Hospital, University of London. Inclusion criteria were: chronic hypertension, gestational hypertension or high risk of developing pre-eclampsia, no significant proteinuria (≤ 1+ proteinuria on dipstick testing) and normal biochemical and hematological markers. Exclusion criteria were maternal age  155 mmHg or diastolic blood pressure > 100 mmHg, significant proteinuria (≥ 2+ proteinuria on dipstick testing or protein/creatinine ratio > 30 mg/mmol), evidence of small-for-gestational age (estimated fetal weight < 10 th centile), signs of severe pre-eclampsia, significant mental health concerns or insufficient understanding of the English language. Pregnant women in the HBPM group were taught how to measure and record their blood pressure using a validated machine at home and attended every 1-2 weeks for assessment depending on clinical need. The control group was managed as per the local protocol prior to the implementation of HBPM. The two groups were compared with respect to number of visits to antenatal services and outcome. There were 108 women in the HBPM group and 58 in the control group. There was no difference in maternal age, parity, body mass index, ethnicity or smoking status between the groups, but there were more women with chronic hypertension in the HBPM group compared with the control group (49.1% vs 25.9%, P = 0.004). The HBPM group had significantly fewer outpatient attendances per patient (6

Adjuvant treatment with monosialoganglioside may improve neurological outcomes in neonatal hypoxic-ischemic encephalopathy: A meta-analysis of randomized controlled trials.

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Lei Sheng

Full Text Available Ganglioside has a neuroprotective role in neonatal hypoxic-ischemic encephalopathy (HIE. This study aimed to evaluate the neurological outcomes of monosialoganglioside as adjuvant treatment for neonatal HIE by conducting a meta-analysis.A comprehensive literature search was made in the Pubmed, EMBASE, Cochrane Library, Wanfang, CNKI, VIP databases through October 2016. Randomized controlled trials comparing monosialoganglioside with the usual treatment for newborns having HIE deemed eligible. Weighted mean difference (WMD and risk ratio (RR with 95% confidence interval (CI were calculated for continuous and dichotomous data, respectively.Ten trials consisting of 787 neonates were included. Adjuvant treatment with monosialoganglioside significantly reduced major neurodevelopmental disabilities (RR = 0.35; 95% CI = 0.21-0.57, cerebral palsy (RR = 0.32; 95% CI = 0.12-0.87, mental retardation (RR = 0.31; 95% CI = 0.11-0.88 as well as improved the mental (WMD = 14.95; 95% CI = 7.44-22.46 and psychomotive (WMD = 13.40; 95% CI = 6.69-20.11 development index during the follow-up. Also, monosialoganglioside significantly improved Neonatal Behavioral Neurological Assessment scores (WMD = 2.91; 95% CI = 2.05-3.78 compared with the usual treatment. However, adverse effects associated with monosialoganglioside were poorly reported in the included trials.Adjuvant treatment with monosialoganglioside had beneficial effects in improving neurological outcomes in neonatal HIE. However, these findings should be interpreted with caution because of methodological flaws in the included trials. Furthermore, safety of monosialoganglioside use should also be further evaluated.

Criteria-based audit of quality of care to women with severe pre-eclampsia and eclampsia in a referral hospital in Accra, Ghana.

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Joyce L Browne

Full Text Available Severe pre-eclampsia and eclampsia are one of the major causes of maternal mortality globally. Reducing maternal morbidity and mortality demands optimizing quality of care. Criteria-based audits are a tool to define, assess and improve quality of care. The aim of this study was to determine applicability of a criteria-based audit to assess quality of care delivered to women with severe hypertensive disorders in pregnancy, and to assess adherence to protocols and quality of care provided at a regional hospital in Accra, Ghana.Checklists for management of severe preeclampsia, hypertensive emergency and eclampsia were developed in an audit cycle based on nine existing key clinical care protocols. Fifty cases were audited to assess quality of care, defined as adherence to protocols. Analysis was stratified for complicated cases, defined as (imminent eclampsia, perinatal mortality and/or one or more WHO maternal near miss C-criteria.Mean adherence to the nine protocols ranged from 15-85%. Protocols for 'plan for delivery' and 'magnesium sulphate administration' were best adhered to (85%, followed by adherence to protocols for 'eclampsia' (64%, 'severe pre-eclampsia at admission' (60%, 'severe pre-eclampsia ward follow-up' (53% and 'hypertensive emergency' (53%. Protocols for monitoring were least adhered to (15%. No difference was observed for severe disease. Increased awareness, protocol-based training of staff, and clear task assignment were identified as contributors to better adherence.A criteria-based audit is an effective tool to determine quality of care, identify gaps in standard of care, and allow for monitoring and evaluation in a health facility, ultimately resulting in improved quality of care provided and reduced maternal morbidity and mortality. In our audit, good adherence was observed for plan for delivery and treatment with magnesium sulphate. Substandard adherence to a number of protocols was identified, and points towards

Poor periodontal health as a risk factor for development of pre-eclampsia in pregnant women

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Shailesh Varshney

2014-01-01

Full Text Available Aims: Periodontal disease has been considered a systemic exposure implicated in a higher risk of adverse pregnancy outcomes. The aim of the present study was to determine whether maternal oral health is associated with an increased risk of pre-eclampsia. Subjects and Methods: A case-control study was conducted which included 40 pregnant women patients admitted to the Department of Obstetrics and Gynecology, J.N. Medical College, A.M.U, Aligarh. Pre-eclampsia was defined as classic triad of hypertension, proteinuria and symptoms such as swelling/edema esp. in hands and face, headache, visual changes etc., A periodontal examination was done during 48 h after child delivery. Maternal oral status was evaluated using gingival index by Loe and Silness, oral hygiene index (simplified by greene and vermillion and periodontal pockets and clinical attachment level (CAL. Statistical Analysis: Null hypothesis that no difference exist between the two groups (pre-eclamptic and non-pre-eclamptic Group was calculated using paired t-test, Chi-square and Mann-Whitney U statistical tests using SPSS 11.5 (Statistical Package for Social sciences, Chicago. P < 0.05 was considered to be statistically significant. Results: The amount of gingival inflammation, oral hygiene levels, pocket depth and CALs as measured by their respective indices were higher in the pre-eclamptic group when compared to non-pre-eclamptic group. Furthermore CAL was significantly increased in the test group. This study showed that pre-eclamptic cases were more likely to develop periodontal disease (P < 0.05. 30% of the test group and 65% of the case group had periodontal disease (P < 0.05 which had shown that pre-eclamptic cases were 4.33 times more likely to have periodontal disease (odds ratio = 4.33. Conclusions: Maternal oral status was determined to be associated with an increased risk of pre-eclampsia.

Outcomes in registered, ongoing randomized controlled trials of patient education.

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Cécile Pino

Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

Impact of Maternal Body Mass Index on Intrapartum and Neonatal Outcomes in Brisbane, Australia, 2007 to 2013.

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Foo, Xin Y; Greer, Ristan M; Kumar, Sailesh

2016-12-01

The aim of this study was to evaluate the influence of maternal body mass index on intrapartum and neonatal outcomes at one of the largest maternity hospitals in Australia. A retrospective cross-sectional study of 55,352 term singleton deliveries at the Mater Mothers' Hospital in Brisbane, Australia, was conducted. The study cohort was stratified into six groups based on the World Health Organization's body mass index classification. The normal body mass index category was the reference group for all comparisons. Multivariate logistic regression was used to examine the effect of maternal body mass index, adjusted for maternal age, ethnicity, parity, and preexisting conditions (e.g., diabetes mellitus and hypertension), on selected intrapartum and neonatal outcomes. Women in the overweight and Obese I, II, and III categories were more likely to have chronic or gestational hypertension/preeclampsia, and preexisting or gestational diabetes mellitus. They also had an increased risk for induction of labor, elective and emergency cesarean, and postpartum hemorrhage. Underweight women were less likely to require induction of labor and emergency cesarean. Infants born to women with increased body mass index were more likely to require neonatal resuscitation, neonatal intensive care unit admission, and have lower Apgar scores at 5 minutes. There is an increased risk of adverse intrapartum and neonatal outcomes for women who are overweight and obese, with the risks increasing with rising body mass index. Appropriately targeted weight management strategies and health education may yield improved maternal and perinatal outcomes if effectively implemented before pregnancy. These may particularly be of benefit in the teenage cohort that has yet to embark on pregnancy. © 2016 Wiley Periodicals, Inc.

Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

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Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

2016-01-01

Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

Effect of Turkish classical music on prenatal anxiety and satisfaction: A randomized controlled trial in pregnant women with pre-eclampsia.

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Toker, Eylem; Kömürcü, Nuran

2017-02-01

The present study aimed to evaluate the effect of music therapy on anxiety and satisfaction in pregnant women with preeclampsia. A randomized controlled trial was performed on 70 pregnant women with pre-eclampsia hospitalized in the research and application hospital of Kahramanmaras Sütcü İmam University between December 2012 and February 2014. The subjects were allocated to experimental or control groups in a random manner (n=35 each). Pregnant women in the experimental group were subject to a 30min Turkish classical music therapy trial each day for a period of 7days (5days before and 2days after labor) whereas those in the control group received routine care and also were assigned to 30min of bed rest a day. The Personal Information Form, State-Trait Anxiety Inventory, and Newcastle Satisfaction with Nursing Scale were administered to participants. Data were analyzed using descriptive statistics, student t-test, and Mann-Whitney U test where appropriate. Outcome measures were anxiety scale scores, satisfaction scale scores, vital signs, fetal movement and fetal heart rate. The differences between anxiety scores were not statistically significant (p>0.05). On the other hand, Newcastle Satisfaction with Nursing Scale scores of the experiment group were higher than the control group (pusic Therapy had a minimalizing effect on fetal heart rate and a lowering effect on blood pressure (pusic therapy in the care and follow-up of pregnant women with preeclampsia in obstetrics units. Copyright © 2016 Elsevier Ltd. All rights reserved.

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

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Neto José

2011-03-01

Full Text Available Abstract Background Blood pressure (BP within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage. Methods This is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution. Discussion The early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe

A clinical evaluation of placental growth factor in routine practice in high-risk women presenting with suspected pre-eclampsia and/or fetal growth restriction.

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Ormesher, L; Johnstone, E D; Shawkat, E; Dempsey, A; Chmiel, C; Ingram, E; Higgins, L E; Myers, J E

2018-03-13

To evaluate the use of plasma Placental Growth Factor (PlGF), recommended by the recent NICE guidance, in women with suspected pre-eclampsia (PE) and/or fetal growth restriction (FGR). Non-randomised prospective clinical evaluation study in high-risk antenatal clinics in a tertiary maternity unit. PlGF testing was performed in addition to routine clinical assessment in 260 women >20 weeks' gestation with chronic disease (hypertension, renal disease ± diabetes) with a change in maternal condition or in women with suspected FGR to determine the impact on clinical management. Results were revealed and standardised care pathways followed. Outcome of pregnancies with a low PlGF (women had an adverse outcome (PE/birthweight women with PlGF 14 days. The PlGF result altered clinical management (surveillance or timing of birth) in 196/260 (75.4%) cases. Alternative PlGF thresholds did not significantly improve diagnostic performance. Our evaluation confirms the value of PlGF as a diagnostic tool for placental dysfunction. However, low PlGF in isolation should not trigger iatrogenic delivery. Further research linking placental pathology, maternal disease and maternal PlGF levels is urgently needed before this test can be implemented in routine clinical practice. Copyright © 2018. Published by Elsevier B.V.

Spontaneous Pushing in Lateral Position versus Valsalva Maneuver During Second Stage of Labor on Maternal and Fetal Outcomes: A Randomized Clinical Trial.

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Vaziri, Farideh; Arzhe, Amene; Asadi, Nasrin; Pourahmad, Saeedeh; Moshfeghy, Zeinab

2016-10-01

There are concerns about the harmful effects of the Valsalva maneuver during the second stage of labor. Comparing the effects of spontaneous pushing in the lateral position with the Valsalva maneuver during the second stage of labor on maternal and fetal outcomes. Inclusion criteria in this randomized clinical trial conducted in Iran were as follows: nulliparous mothers, live fetus with vertex presentation, gestational age of 37 - 40 weeks, spontaneous labor, and no complications. The intervention group pushed spontaneously while they were in the lateral position, whereas the control group pushed using Valsalva method while in the supine position at the onset of the second stage of labor. Maternal outcomes such as pain and fatigue severity and fetal outcomes such as pH and pO2 of the umbilical cord blood were measured. Data pertaining to 69 patients, divided into the intervention group (35 subjects) and control group (34 subjects), were analyzed statistically. The mean pain (7.80 ± 1.21 versus 9.05 ± 1.11) and fatigue scores (46.59 ± 21 versus 123.36 ± 43.20) of the two groups showed a statistically significant difference (P pushing in the lateral position reduced fatigue and pain severity of the mothers. Also, it did not worsen fetal outcomes. Thus, it can be used as an alternative method for the Valsalva maneuver.

Hypertensive disorders of pregnancy: frequency, maternal and fetal outcomes

International Nuclear Information System (INIS)

Nisar, N.; Memon, A.; Sohoo, N.A; Ahmed, M.

2010-01-01

To determine the frequency and distribution of different types of hypertensive disorders of pregnancy and to determine the impact of hypertensive disorders of pregnancy (HDP) on maternal and fetal outcomes. All the patients who were diagnosed to have hypertensive disorders of pregnancy during study period were categorized as group I. One hundred nineteen women delivered during the same period without hypertensive disorders of pregnancy were included as group II. The data regarding demographic and obstetrical parameters, associated risk factors, fetal and maternal complications were gathered from available data on medical record files. Total number of deliveries during the same period was obtained. Frequency of hypertensive disorders of pregnancy was calculated. Statistical analysis was performed by SPSS V11. Pearson's chi square and student's t test was used for comparison of variables in between two groups. P value < 0.05 was considered significant. The frequency of Hypertensive disorders of pregnancy was 8.9% in our study. The mean maternal age was 28.57+-5.8 years and 26.56+-5.0 years for group I and II respectively. Forty eight (76.2%) of group I patients were Unbooked for antenatal care, 37(58.7%) belonged to poor socioeconomic status and 82(45.1%) were multipara. Statistically significant difference was found for antenatal booking status (P. 0.04) and socioeconomic status (P. 0.01) and parity (P 0.04) in both groups. Twenty three (36.5%) patients from group I had past history of hypertensive disorders of pregnancy, while it was reported only by 8(6.7%) of group II patients. It was observed that women with HDP have strong family history of hypertension (P. <0.001). Regarding maternal outcome more patients from group I were shifted to ICU as compared to group II. Maternal mortality was significantly high in group I (P <0.001). The mean gestational age was 35.29+-2.6 weeks and 38.03+-1.3 weeks in group I and II respectively. The mean birth weight of baby was 2

Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial.

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van Klink, Jeanine M M; van Veen, Suzanne J; Smits-Wintjens, Vivianne E H J; Lindenburg, Irene T M; Rijken, Monique; Oepkes, Dick; Lopriore, Enrico

2016-01-01

Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings. © 2015 S. Karger AG, Basel.

Review on pre-eclampsia

OpenAIRE

Schlembach, Dietmar

2003-01-01

Pre-eclampsia is still one of the leading causes of maternal and fetal morbidity and mortality. Despite active research for many decades, the etiology of this disorder exclusive to human pregnancy is an enigma. Recent evidence suggests there may be several underlying causes or predispositions leading to endothelial dysfunction and causing the signs of hypertension, proteinuria, and edema--findings that allow us to make the diagnosis of the "syndrome" of pre-eclampsia. It is obvious that a sin...

Maternal and foetal outcome in hellp syndrome at tertiary care hospital

International Nuclear Information System (INIS)

Sadaf, N.; Haq, G.; Din, S.S.U.

2013-01-01

Objective: To determine maternal and foetal outcome in patients of Haemolysis, Elevated Liver enzyme and Low Platelet Cont syndrome. Methods: The descriptive case series was conducted at the Gynae Unit II of Civil Hospital, Karachi, over a period of 12 months in two episodes; first from December 28, 2006, to February 28, 2007, and then from September 1, 2007, to June 30, 2008. It comprised 40 consecutive women with pre-ecampsia and eclampsia along with altered platelet count who met the syndrome criteria. A pre-designed proforma was administered for data collection. Maternal and foetal outcomes were noted. SPSS 10 was used for statistical analysis. Result: Among the 40 mothers, cesarean section was the most common outcome (n=24; 60%). Pulmonary oedema was found in 2 (5%) cases, acute renal failure in 10 (25%), disseminated intravascular coagulation in 6 (15%), and abruptio placenta in 5 (12.5%). Intrauterine growth restriction as a foetal outcome was observed in 18 (45%) cases. Pre-term birth was the result in 20 (50%) cases, and perinatal mortality was high (n=23; 57.5%). Conclusion: Management and delivery of HELLP syndrome patients should be performed at tertiary care centres, where highly trained obstetrician, neonatal intensive care unit personnel and Multi-disciplinary facilities are available. Correct diagnosis and timely intervention can decrease the risk of maternal and perinatal mortality. (author)

Maternal body mass index and risk of birth and maternal health outcomes in low- and middle-income countries: a systematic review and meta-analysis.

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Rahman, M M; Abe, S K; Kanda, M; Narita, S; Rahman, M S; Bilano, V; Ota, E; Gilmour, S; Shibuya, K

2015-09-01

We conducted a systematic review and meta-analysis of population-based cohort studies of maternal body mass index (BMI) and risk of adverse birth and health outcomes in low- and middle-income countries. PubMed, Embase, CINAHL and the British Nursing Index were searched from inception to February 2014. Forty-two studies were included. Our study found that maternal underweight was significantly associated with higher risk of preterm birth (odds ratio [OR], 1.13; 95% confidence interval [CI], 1.01-1.27), low birthweight (OR, 1.66; 95% CI, 1.50-1.84) and small for gestational age (OR, 1.85; 95% CI, 1.69-2.02). Compared with mothers with normal BMI, overweight or obese mothers were at increased odds of gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, caesarean delivery and post-partum haemorrhage. The population-attributable risk (PAR) indicated that if women were entirely unexposed to overweight or obesity during the pre-pregnancy or early pregnancy period, 14% to 35% fewer women would develop gestational diabetes, pre-eclampsia or pregnancy-induced hypertension in Brazil, China, India, Iran or Thailand. The highest PAR of low birthweight attributable to maternal underweight was found in Iran (20%), followed by India (18%), Thailand (10%) and China (8%). Treatment and prevention of maternal underweight, overweight or obesity may help reduce the burden on maternal and child health in developing countries. © 2015 World Obesity.

Thyroid dysfunction and pregnancy outcomes

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Sima Nazarpour

2015-07-01

Full Text Available Background: Pregnancy has a huge impact on the thyroid function in both healthy women and those that have thyroid dysfunction. The prevalence of thyroid dysfunction in pregnant women is relatively high. Objective: The objective of this review was to increase awareness and to provide a review on adverse effect of thyroid dysfunction including hyperthyroidism, hypothyroidism and thyroid autoimmune positivity on pregnancy outcomes. Materials and Methods: In this review, Medline, Embase and the Cochrane Library were searched with appropriate keywords for relevant English manuscript. We used a variety of studies, including randomized clinical trials, cohort (prospective and retrospective, case-control and case reports. Those studies on thyroid disorders among non-pregnant women and articles without adequate quality were excluded. Results: Overt hyperthyroidism and hypothyroidism has several adverse effects on pregnancy outcomes. Overt hyperthyroidism was associated with miscarriage, stillbirth, preterm delivery, intrauterine growth retardation, low birth weight, preeclampsia and fetal thyroid dysfunction. Overt hypothyroidism was associated with abortion, anemia, pregnancy-induced hypertension, preeclampsia, placental abruption, postpartum hemorrhage, premature birth, low birth weight, intrauterine fetal death, increased neonatal respiratory distress and infant neuro developmental dysfunction. However the adverse effect of subclinical hypothyroidism, and thyroid antibody positivity on pregnancy outcomes was not clear. While some studies demonstrated higher chance of placental abruption, preterm birth, miscarriage, gestational hypertension, fetal distress, severe preeclampsia and neonatal distress and diabetes in pregnant women with subclinical hypothyroidism or thyroid autoimmunity; the other ones have not reported these adverse effects. Conclusion: While the impacts of overt thyroid dysfunction on feto-maternal morbidities have been clearly

A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy.

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Akula, Vishnu Priya; Joe, Priscilla; Thusu, Kajori; Davis, Alexis S; Tamaresis, John S; Kim, Sunhwa; Shimotake, Thomas K; Butler, Stephen; Honold, Jose; Kuzniewicz, Michael; DeSandre, Glenn; Bennett, Mihoko; Gould, Jeffrey; Wallenstein, Matthew B; Van Meurs, Krisa

2015-04-01

To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice. We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California. Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling. The primary outcome was the percentage of temperatures in target range (33°-34°C) during transport. Secondary outcomes included percentage of newborns reaching target temperature any time during transport, time to target temperature, and percentage of newborns in target range 1 hour after cooling initiation. One hundred newborns were enrolled: 49 to control arm and 51 to device arm. Baseline demographics did not differ with the exception of cord pH. For each subject, the percentage of temperatures in the target range was calculated. Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants (median 73% [IQR 17-88] vs 0% [IQR 0-52], P newborns with neonatal encephalopathy. Copyright © 2015 Elsevier Inc. All rights reserved.

Effect of hydralazine on duration of soft tissue local anesthesia following dental treatment: a randomized clinical trial.

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Fakheran Esfahani, Omid; Pouraboutaleb, Mohammad Fazel; Khorami, Behnam

2015-01-01

Prolonged numbness following routine dental treatments can cause difficulties in speaking and swallowing and may result in inadvertent biting of soft tissues. Local injection of vasodilator agents may represent a solution to this problem. The aim of this study was to evaluate the effect of submucosal injection of hydralazine hydrochloride (HCl) on the duration of oral soft tissue anesthesia after routine dental treatment. This randomized, single-blinded, controlled clinical trial included 50 patients who received inferior alveolar nerve block (2% lidocaine with 1:100,000 epinephrine) for simple restorative treatment. Upon completion of the dental treatment, patients randomly received a hydralazine HCl or sham injection in the same site as the local anesthetic injection. The reversal time to normal sensation of soft tissues (lips, tongue, and perioral skin) was evaluated and reported every 5 minutes by the patients, who followed an assessment protocol that they were taught in advance of treatment. Median recovery times in the hydralazine group and the sham group were 81.4 (SD, 3.6) and 221.8 (SD, 6.3) minutes, respectively. Based on Kaplan-Meier survival analysis, the duration of soft tissue anesthesia in the 2 groups was significantly different (P local anesthetic-induced soft tissue numbness and the related functional problems.

Comparison of maternal and fetal outcomes among patients undergoing cesarean section under general and spinal anesthesia: a randomized clinical trial

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Anıl İçel Saygı

Full Text Available CONTEXT AND OBJECTIVE: As the rates of cesarean births have increased, the type of cesarean anesthesia has gained importance. Here, we aimed to compare the effects of general and spinal anesthesia on maternal and fetal outcomes in term singleton cases undergoing elective cesarean section.DESIGN AND SETTING: Prospective randomized controlled clinical trial in a tertiary-level public hospital.METHODS: Our study was conducted on 100 patients who underwent cesarean section due to elective indications. The patients were randomly divided into general anesthesia (n = 50 and spinal anesthesia (n = 50 groups. The maternal pre and postoperative hematological results, intra and postoperative hemodynamic parameters and perinatal results were compared between the groups.RESULTS: Mean bowel sounds (P = 0.036 and gas discharge time (P = 0.049 were significantly greater and 24th hour hemoglobin difference values (P = 0.001 were higher in the general anesthesia group. The mean hematocrit and hemoglobin values at the 24th hour (P = 0.004 and P < 0.001, respectively, urine volume at the first postoperative hour (P < 0.001 and median Apgar score at the first minute (P < 0.0005 were significantly higher, and the time that elapsed until the first requirement for analgesia was significantly longer (P = 0.042, in the spinal anesthesia group.CONCLUSION: In elective cases, spinal anesthesia is superior to general anesthesia in terms of postoperative comfort. In pregnancies with a risk of fetal distress, it would be appropriate to prefer spinal anesthesia by taking the first minute Apgar score into account.

ECLAMPSIA, A MAJOR BURDEN ON MATERNAL AND CHILD HEALTH: A RETROSPECTIVE STUDY IN TERTIARY CARE CENTRE

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Kanchan Rani

2017-01-01

Full Text Available BACKGROUND Eclampsia is very common obstetric emergency and major cause of both maternal and perinatal morbidity and mortality in India. AIM The aim of study was to evaluate its incidence, clinical profile and maternal and perinatal morbidity and mortality associated with it in our hospital. MATERIALS AND METHODS A retrospective study was conducted in Government medical college, Haldwani from August 2014 to July 2015 for a period of one year. Out of 3432 deliveries a total of 53 cases of eclampsia were admitted .Cases were studied with respect to age, parity, period of gestation, blood pressure at the time of admission, severity of proteinuria ,maternal complications and mortality, mode of delivery and perinatal outcome. RESULTS Incidence of eclampsia in our study was 1.45%. Majority of patient were primigravida (62.26% It was more common in age group of 21 to 25 years (43.39% followed by age group of 26 to 30 years (26.41%.In most of patient first episode of convulsion occurred at term pregnancy with gestational age more than 37 weeks in our study (52.83%.Among 53 patients of eclampsia 48 presented with antepartum eclampsia (90.57% and 5 presented as postpartum eclampsia (9.43%. There was no case of intrapartum eclampsia in our study. Most common mode of delivery was Lower Segment Caesarean Section (62.26% in our study. Among 53 cases of eclampsia 3 patient had pulmonary oedema, 3 patient developed postpartum pyrexia and 4 patient had placental abruption. In one case postpartum haemorrhage occurred and one patient was in acute renal failure. There was one maternal mortality in our study. 6 patient had intrauterine foetal death (11.32%. 25 had preterm delivery (47.16% and 16 newborns were of low birth weight less than 2.5 Kilograms (30.19%. Most patient who developed eclampsia were unbooked or had irregular or no antenatal check-up (94.33%. CONCLUSION Improvement in antenatal care and neonatal facilities is of paramount importance in decreasing

Development of composite outcomes for individual patient data (IPD) meta-analysis on the effects of diet and lifestyle in pregnancy

DEFF Research Database (Denmark)

Rogozinska, Ewelina; D'Amico, M. I.; Khan, Khalid S

2016-01-01

Objective To develop maternal, fetal, and neonatal composite outcomes relevant to the evaluation of diet and lifestyle interventions in pregnancy by individual patient data (IPD) meta-analysis. Design Delphi survey. Setting The International Weight Management in Pregnancy (i-WIP) collaborative...... by IPD meta-analysis. Tweetable abstract Composite outcomes in IPD meta-analysis on diet and lifestyle in pregnancy. Tweetable abstract Composite outcomes in IPD meta-analysis on diet and lifestyle in pregnancy. This article includes Author Insights, a video abstract available at https...... and the following were included in the final composite: pre-eclampsia or pregnancy-induced hypertension, gestational diabetes mellitus (GDM), elective or emergency caesarean section, and preterm delivery. Of the 27 fetal and neonatal outcomes, nine were further evaluated, with the final composite consisting...

Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial.

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Rodda, C P; Benson, J E; Vincent, A J; Whitehead, C L; Polykov, A; Vollenhoven, B

2015-09-01

To determine whether maternal vitamin D supplementation, in the vitamin D deficient mother, prevents neonatal vitamin D deficiency. Open-label randomized controlled trial. Metropolitan Melbourne, Australia, tertiary hospital routine antenatal outpatient clinic. Seventy-eight women with singleton pregnancies with vitamin D deficiency/insufficiency (serum 25-OH Vit D l) at their first antenatal appointment at 12-16-week gestation were recruited. Participants were randomized to vitamin D supplementation (2000-4000 IU cholecalciferol) orally daily until delivery or no supplementation. The primary outcome was neonatal serum 25-OH vit D concentration at delivery. The secondary outcome was maternal serum 25-OH vit D concentration at delivery. Baseline mean maternal serum 25-OH vit D concentrations were similar (P = 0·9) between treatment (32 nmol/l, 95% confidence interval 26-39 nmol/l) and control groups (33 nmol/l, 95% CI 26-39 nmol/l). Umbilical cord serum 25-OH vit D concentrations at delivery were higher (P l, 95% CI; 70-91 nmol/l) compared with neonates of control group mothers (42 nmol/l, 95% CI; 34-50 nmol/l) with a strongly positive correlation between maternal serum 25-OH Vit D and umbilical cord serum 25-OH vit D concentrations at delivery (Spearman rank correlation coefficient 0·88; P l, 95% CI; 62-81 nmol/l) compared with the control group (36 nmol/l, 95% CI; 29-42 nmol/l). Vitamin D supplementation of vitamin D deficient pregnant women prevents neonatal vitamin D deficiency. © 2015 John Wiley & Sons Ltd.

Multidisciplinary approach to management of maternal asthma (MAMMA [copyright]): the PROTOCOL for a randomized controlled trial.

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Lim, Angelina; Stewart, Kay; Abramson, Michael J; Walker, Susan P; George, Johnson

2012-12-19

Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy. A pilot single-blinded parallel-group randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA©) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV(1)/FEV(6) will be also investigated during this trial as a marker for asthma control. If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma

Maternal and fetal outcomes of intimate partner violence associated with pregnancy in the Latin American and Caribbean region.

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Han, Alice; Stewart, Donna E

2014-01-01

Very high rates of intimate partner violence during pregnancy (IPV-P) are reported in Latin America and the Caribbean (LAC) but data on prevalence and obstetric-related outcomes are limited. To conduct a literature review on risk factors, prevalence, and adverse obstetric-related outcomes of IPV-P in LAC. Systematic review of studies in MEDLINE (1946-2012) and LILACS (1982-2012), and hand searching of reference lists of included studies. Search terms were variations of partner abuse and pregnancy in LAC. Studies were excluded if they did not include IPV-P prevalence or if the perpetrator was not an intimate partner. Study quality was assessed via US Preventive Services Task Force criteria. In the 31 studies included, prevalence rates ranged from 3% to 44%. IPV-P was significantly associated with unintended pregnancies and adverse maternal (depression, pregnancy-related symptom distress, inadequate prenatal care, vaginal bleeding, spontaneous abortion, gestational weight gain, high maternal cortisol, hypertension, pre-eclampsia, STIs) and infant (prematurity, low birth weight, neonatal complications, stillbirth) outcomes (grade II-2 and 3 evidence). IPV-P is highly prevalent in LAC, with poor obstetric-related outcomes. Clinicians must identify women experiencing IPV-P and institute appropriate interventions and referrals to avoid its deleterious consequences. © 2013.

A controlled trial of the effect of aromatherapy on birth outcomes using "Rose essential oil" inhalation and foot bath

OpenAIRE

Masoomeh Kheirkhah; Nassimeh Setayesh Valipour; Leila Neisani; Hamid Haghani

2013-01-01

Background and aim: Aromatherapy is the art and science of using essential oils extracted from aromatic plants, and is concerned with natural balance, coordination and promotion of health. This study was designed to determine the effect of "rose (Rosa damascena) essential oil" inhalation and foot bath on the improvement of maternal and neonatal health outcomes. Material and methods: This study was a randomized clinical trial, conducted on 80 primiparous women in Shahid Akbar Abadi Maternity H...

Therapist facilitative interpersonal skills and training status: A randomized clinical trial on alliance and outcome.

Science.gov (United States)

Anderson, Timothy; Crowley, Mary Ellen J; Himawan, Lina; Holmberg, Jennifer K; Uhlin, Brian D

2016-09-01

Therapist effects, independent of the treatment provided, have emerged as a contributor to psychotherapy outcomes. However, past research largely has not identified which therapist factors might be contributing to these effects, though research on psychotherapy implicates relational characteristics. The present Randomized Clinical Trial tested the efficacy of therapists who were selected by their facilitative interpersonal skills (FIS) and training status. Sixty-five clients were selected from 2713 undergraduates using a screening and clinical interview procedure. Twenty-three therapists met with 2 clients for 7 sessions and 20 participants served in a no-treatment control group. Outcome and alliance differences for Training Status were negligible. High FIS therapists had greater pre-post client outcome, and higher rates of change across sessions, than low FIS therapists. All clients treated by therapists improved more than the silent control, but effects were greater with high FIS than low FIS therapists. From the first session, high FIS therapists also had higher alliances than low FIS therapists as well as significant improvements on client-rated alliance. Results were consistent with the hypothesis that therapists' common relational skills are independent contributors to therapeutic alliance and outcome.

OUTCOMES in CHILDHOOD FOLLOWING THERAPEUTIC HYPOTHERMIA for NEONATAL HYPOXIC-ISCHEMIC ENCEPHALOPATHY (HIE)

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Natarajan, Girija; Pappas, Athina; Shankaran, Seetha

2017-01-01

In this chapter we review the childhood outcomes of neonates with birth depression and/or hypoxic-ischemic encephalopathy. The outcomes of these children prior to the era of hypothermia for neuroprotection will first be summarized, followed by discussion of results from randomized controlled trials of therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy. The predictors of outcome in childhood following neonatal HIE using clinical and imaging biomarkers following hypothermia therapy will be described. PMID:27863707

Maternal, Fetal and Neonatal Outcomes in Pregnant Women with Systemic Lupus Erythematosus: A Comprehensive Review Study

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Fatemeh Zahra Karimi

2017-11-01

Full Text Available Background:Systemic lupus erythematosus (SLE is an autoimmune disease with multiple organ involvement and periods of relapse and remission that mainly affects young women of childbearing age. In this regard the reproductive health is an important issue. Although diagnosis, treatment and management of pregnancy in SLE women have been improved recently, but the main concern is effects of SLE on maternal, fetal and neonatal outcomes. This study aimed to investigate the maternal, fetal and neonatal outcomes in pregnant women with SLE. Materials and Methods: The databases of PubMed, Medline, Scopus and Web of Science as well as domestic database (Persian such as SID, Magiran, Irandoc, and Google Scholar were searched with using keywords such as" Systemic lupus erythematosus"; "Pregnancy"; "Neonatal lupus"; "maternal, fetus or neonatal outcome";  and equivalent Persian words. Included were all Persian and English articles, published between 2000 and May 2017. Finally, a total of 77 studies were included. Results: Adverse perinatal outcomes increase in pregnancies with lupus. Outcomes include respiratory, cardiovascular, blood and skin disorders in mothers; stillbirth, spontaneous, and recurrent abortion in fetuses and neonatal lupus, prematurity, intrauterine growth restriction (IUGR, and small for gestational age (SGA in neonates, respectively. Conclusion: Pregnant women with SLE are at high risk due to increased complications for both mother and fetus. It seems broad control of the women before fertilization, so that they be at full remission in the beginning of pregnancy and the disease activity be in complete control, it can help to improve outcomes of pregnancy and so better results can be expected.

Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial.

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Sharara-Chami, Rana; Lakissian, Zavi; Charafeddine, Lama; Milad, Nadine; El-Hout, Yaser

2017-12-01

There is no consensus on the most effective pain management for neonatal circumcision. We sought to compare different modalities. This is a double-blinded randomized controlled trial comparing 3 combination analgesics used during circumcision (EMLA + sucrose; EMLA + sucrose + dorsal penile nerve block [DPNB]; EMLA + sucrose + ring block [RB]) with the traditional topical analgesic cream EMLA alone. The trial was set in the normal nursery of a teaching hospital. The sample included 70 healthy male newborns, randomly assigned to intervention and control groups at a 2:1 ratio. Infants were videotaped (face and torso) during the procedure for assessment of pain by 2 blinded, independent reviewers. The primary outcome measure is the Neonatal Infant Pain Scale score. Secondary outcomes include heart rate, oxygen saturation, and crying time. Neonatal Infant Pain Scale scores were significantly lower in the intervention groups (EMLA + sucrose, mean [SD]: 3.1 [1.33]; EMLA + sucrose + DPNB: 3 [1.33]; EMLA + sucrose + RB: 2.45 [1.27]) compared with the control (5.5 [0.53]). Between-group analyses showed RB + EMLA + sucrose to be significantly more effective than EMLA + sucrose; EMLA + sucrose + DPNB ( P = .009 and P = .002, respectively). Interrater reliability was κ = 0.843. Significant increase in heart rate (139.27 [9.63] to 163 [13.23] beats per minute) and crying time (5.78 [6.4] to 45.37 [12.39] seconds) were noted in the EMLA group. During neonatal circumcision in boys, the most effective analgesia is RB combined with oral sucrose and EMLA cream. Copyright © 2017 by the American Academy of Pediatrics.

MEASURES TO IMPROVE THE OUTCOME OF ABRUPTIO PLACENTA IN A TERTIARY REFERRAL CENTRE

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Vijaya

2015-12-01

Full Text Available AIM To analyze the outcome of 135 patients admitted with Abruptio Placenta during a period of 9 months managed at Tertiary Referral Centre, Modern Govt. Maternity Hospital, Petalburz, Hyderabad, Telangana State. MATERIALS AND METHODS A study of 135 cases of Abruptio Placenta over a period of 9 months at a tertiary level referral centre. They were analyzed regarding age, parity, socio economic status, period of gestation, antenatal care, management of Abruption and maternal and fetal outcome, and the measures to improve the condition were analyzed. RESULTS Abruptio placenta is a dreadful threat to maternal and fetal life. In our study unbooked cases were 110(81.48%, Hypertension is the main risk factor almost in 90(66.66% cases, 65% of them were between 28-36 weeks of GA, and 6 were grandmultis, 6 cases ended up with HELLP syndrome with DIC. All these 6 cases were near misses, 5 unbooked cases had eclampsia. One case of unbooked eclampsia had abruption DIC and could not be saved as it was the late referral. Total number of vaginal deliveries were 66(48.88% and total no. of abdominal deliveries were 67(49.62% in this LSCS 66 and one hysterotomy. IUD at the time of admission total were 100(74%. CONCLUSION To improve the outcome in Abruptio Placentae Good antenatal care, Educating the patient, Strengthening the Primary Health Centers in identifying the risk factors like Pre-eclampsia thereby avoiding eclampsia. Regular antenatal checkups timely delivery and availability of blood and blood products with good Neonatal care unit will help in improving the outcome of Abruptio.

The impact of the maternal-foetal environment on outcomes of surgery for congenital heart disease in neonates.

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Gaynor, James William; Parry, Samuel; Moldenhauer, Julie S; Simmons, Rebecca A; Rychik, Jack; Ittenbach, Richard F; Russell, William W; Zullo, Erin; Ward, John Laurenson; Nicolson, Susan C; Spray, Thomas L; Johnson, Mark P

2018-02-13

Pregnancies with congenital heart disease in the foetus have an increased prevalence of pre-eclampsia, small for gestational age and preterm birth, which are evidence of an impaired maternal-foetal environment (MFE). The impact of an impaired MFE, defined as pre-eclampsia, small for gestational age or preterm birth, on outcomes after cardiac surgery was evaluated in neonates (n = 135) enrolled in a study evaluating exposure to environmental toxicants and neuro-developmental outcomes. The most common diagnoses were transposition of the great arteries (n = 47) and hypoplastic left heart syndrome (n = 43). Impaired MFE was present in 28 of 135 (21%) subjects, with small for gestational age present in 17 (61%) patients. The presence of an impaired MFE was similar for all diagnoses, except transposition of the great arteries (P MFE (14 vs 38 days, P MFE (11.7% vs 2.8%, P = 0.104). However, for the entire cohort, survival at 36 months was greater for those without an impaired MFE (96% vs 68%, P = 0.001). For patients with hypoplastic left heart syndrome, survival was also greater for those without an impaired MFE (90% vs 43%, P = 0.007). An impaired MFE is common in pregnancies in which the foetus has congenital heart disease. After cardiac surgery in neonates, the presence of an impaired MFE was associated with lower survival at 36 months of age for the entire cohort and for the subgroup with hypoplastic left heart syndrome. © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

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Shahraki

2016-09-01

Full Text Available Background Pregnancy-related nausea and vomiting or morning sickness with an overall prevalence rate of 80% is commonly appeared at the eighth week and frequently disappeared in most pregnant females at the 16th week of gestation. The severe form of the condition named hyperemesis occurs in one per 200 to 300 pregnancies; it is accompanied by dehydration, electrolyte instability and nutritional deficits and needs medical interventions. Limited data are available on harmful effects of common antiemetic medications used within pregnancy on human neonates. Objectives The current study aimed to compare the effects of ondansetron and vitamin B6 on neonatal outcome in pregnant females with pregnancy-related nausea and vomiting. Neonatal outcome included the probable difference in neonates’ gestational age, weight, height, head circumference and frequency of apparent congenital anomalies. Methods This randomized double-blinded clinical trial was conducted on 188 primipara singleton pregnant females with pregnancy-related nausea and vomiting who referred to state healthcare centers of Zabol, Iran, in 2014. The pregnant females were randomly assigned to receive drug packages including ondansetron tablets (4 mg or vitamin B6 tablets (40 mg and patients were instructed to take one tablet twice daily. Females were followed up until delivery and neonatal outcomes including any congenital anomaly, weight, height and head circumference at birth were assessed. Results There was no difference between the groups in the mean age of mother and the mean age of gestation. No differences were found between the groups regarding birth weight (3006.93 ± 441.86 versus 2949.65 ± 457.36 g, P= 0.67, height at birth (49.50 ± 1.45 versus 48.97 ± 1.47 cm, P= 0.75 and head circumference at birth (34.23 ± 1.22 versus 33.88 ± 1.26 cm, P = 0.56. No neonatal anomaly was observed in the two groups. Conclusions No significant differences were observed between the groups based

Furosemide versus Hydralazine for Managing Post Partum Hypertension in Severe Preeclampsia: A Comparative Study

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M Behrashi

2012-10-01

Full Text Available Introduction: Gestational hypertension and preeclampsia are important maternal and fetal– infant complications and they can be regarded as the second cause of maternal death as well. The present study aimed to assess the effects of hydralazine and furosemide on blood pressure in sever preeclampsia. Methods: One hundred patients with severe preeclampsia were enrolled. After spontaneous onset of postpartum diuresis and discontinuation of intravenous magnesium sulfate, patients were randomly assigned to receive either Hydralazine10mg QID or furosemide10mg BID for 5 days. Patients’ blood pressure was recorded every 6h and the collected data were compared. Results: Postpartum patients with severe preeclampsia who received furosemide had significantly lower systolic blood pressure by postpartum fifth day(66% compared with 42%, P=0.016;OR=2.6 compared to those who had hydralazine. On the other hand, the time duration of response to treatment was lower in patients who received hydralazine compared with furosemide (24.3h compared with 31.4h; P=0.034. Conclusion: Furosemide proved to be more effective on blood pressure mean reduction compared with Hydralazine in women with sever preeclampsia.

Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial.

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Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Nohr, Ellen A

2013-07-01

To examine the effect of a brief course in self-hypnosis for childbirth on duration of the labor and other birth outcomes. A randomized, controlled, single-blind trial. Aarhus University Hospital Skejby, Denmark. A total of 1222 healthy nulliparous women. A hypnosis group receiving three 1-h lessons in self-hypnosis with additional audio-recordings to ease childbirth, a relaxation group receiving three 1-h lessons in various relaxation methods and mindfulness with audio-recordings for additional training, and a usual-care group receiving only the usual antenatal care were compared. Duration of labor, birth complications, lactation success, caring for the child, and preferred future mode of delivery. No differences were found across the three groups on duration from arriving at the birth department until the expulsive phase of second stage of labor, the duration of the expulsive phase, or other birth outcomes. Fewer emergency and more elective cesarean sections occurred in the hypnosis group. No difference was seen across the groups for lactation success or caring for the child but fewer women in the hypnosis group preferred a cesarean section in future pregnancies because of fear of childbirth and negative birth experiences. Learning self-hypnosis to ease childbirth taught as a brief course failed to show any effects on duration of childbirth and other birth outcomes. © 2013 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2013 Nordic Federation of Societies of Obstetrics and Gynecology.

Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

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Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

2012-12-01

To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A risk prediction model for the assessment and triage of women with hypertensive disorders of pregnancy in low-resourced settings: the miniPIERS (Pre-eclampsia Integrated Estimate of RiSk multi-country prospective cohort study.

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Beth A Payne

2014-01-01

Full Text Available Pre-eclampsia/eclampsia are leading causes of maternal mortality and morbidity, particularly in low- and middle- income countries (LMICs. We developed the miniPIERS risk prediction model to provide a simple, evidence-based tool to identify pregnant women in LMICs at increased risk of death or major hypertensive-related complications.From 1 July 2008 to 31 March 2012, in five LMICs, data were collected prospectively on 2,081 women with any hypertensive disorder of pregnancy admitted to a participating centre. Candidate predictors collected within 24 hours of admission were entered into a step-wise backward elimination logistic regression model to predict a composite adverse maternal outcome within 48 hours of admission. Model internal validation was accomplished by bootstrapping and external validation was completed using data from 1,300 women in the Pre-eclampsia Integrated Estimate of RiSk (fullPIERS dataset. Predictive performance was assessed for calibration, discrimination, and stratification capacity. The final miniPIERS model included: parity (nulliparous versus multiparous; gestational age on admission; headache/visual disturbances; chest pain/dyspnoea; vaginal bleeding with abdominal pain; systolic blood pressure; and dipstick proteinuria. The miniPIERS model was well-calibrated and had an area under the receiver operating characteristic curve (AUC ROC of 0.768 (95% CI 0.735-0.801 with an average optimism of 0.037. External validation AUC ROC was 0.713 (95% CI 0.658-0.768. A predicted probability ≥25% to define a positive test classified women with 85.5% accuracy. Limitations of this study include the composite outcome and the broad inclusion criteria of any hypertensive disorder of pregnancy. This broad approach was used to optimize model generalizability.The miniPIERS model shows reasonable ability to identify women at increased risk of adverse maternal outcomes associated with the hypertensive disorders of pregnancy. It could be

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial.

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Nascimento, L S; Santos, A C; Lucena, Jms; Silva, Lgo; Almeida, Aem; Brasileiro-Santos, M S

2017-06-02

Resistant hypertension is a specific condition that affects approximately 10% of subjects with hypertension, and is characterized by persistently high blood pressure levels even using therapy of three or more antihypertensive agents or with blood pressure control using therapy with four or more antihypertensive agents. Changes in lifestyle, such as physical exercise, are indicated for controlling blood pressure. However, investigating studies about this therapy in individuals with resistant hypertension are few. This is a randomized controlled clinical trial. Forty-eight patients with resistant hypertension will be submitted to perform four short-term interventions: aerobic exercise sessions (mild-, moderate- and high-intensity) and control session, in random order and on separate days. After the short-term sessions, the patients will be randomly allocated into four groups for 8 weeks of follow-up: mild-, moderate- and high-intensity aerobic exercise, and a control group. The primary outcome is the occurrence of blood pressure reduction (office and ambulatory analysis, and acute and chronic effects). Secondary outcomes are autonomic and hemodynamic mechanisms: cardiac and vasomotor autonomic modulation, spontaneous baroreflex sensitivity, forearm blood flow and vascular resistance. The importance of exercise for hypertension has been known for decades, but little is known about the effects on patients with resistant hypertension. This study will help to understand whether different aerobic exercise intensities can induce different responses, as well as by what mechanisms adjustments in blood pressure levels may occur. ClinicalTrials.gov, ID: NCT02670681 . Registered on 28 January 2016 (first version); Brazilian Registry Platform Clinical Trials: protocol RBR-5q24zh . Registered on 24 June 2015.

Effect of vitamin D replacement on maternal and neonatal outcomes: a randomised controlled trial in pregnant women with hypovitaminosis D. A protocol.

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Chakhtoura, M; Nassar, A; Arabi, A; Cooper, C; Harvey, N; Mahfoud, Z; Nabulsi, M; El-Hajj Fuleihan, G

2016-03-08

The vitamin D recommended doses during pregnancy differ between societies. The WHO guidelines do not recommend routine prenatal supplementation, but they underscore the fact that women with the lowest levels may benefit most. The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent. Our hypothesis is that in Middle Eastern pregnant women, a vitamin D dose of 3000 IU/day is required to reach a desirable maternal 25-hydroxyvitamin D [25(OH)D] level, and to positively impact infant bone mineral content (BMC). This is a multicentre blinded randomised controlled trial. Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached. Eligible women will be randomised to daily equivalent doses of cholecalciferol, 600 IU or 3000 IU, from 15 to 18 weeks gestation until delivery. Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery. Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month. A sample size of 280 pregnant women is needed to demonstrate a statistically significant difference in the proportion of women reaching a 25(OH)D level ≥ 50 nmol/L at delivery, and a difference in infant BMC of 6 (10)g, for a 90% power and a 2.5% level of significance. The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using χ(2). An independent t test will be used to compare mean infant BMC between the two arms. The primary analysis is an intention-to-treat analysis of unadjusted results. The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22). The trial results will be published in peer-reviewed medical journals and presented at scientific conferences. NCT02434380

Development and evaluation of an Individualized Outcome Measure (IOM) for randomized controlled trials in mental health.

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Pesola, Francesca; Williams, Julie; Bird, Victoria; Freidl, Marion; Le Boutillier, Clair; Leamy, Mary; Macpherson, Rob; Slade, Mike

2015-12-01

Pre-defined, researcher-selected outcomes are routinely used as the clinical end-point in randomized controlled trials (RCTs); however, individualized approaches may be an effective way to assess outcome in mental health research. The present study describes the development and evaluation of the Individualized Outcome Measure (IOM), which is a patient-specific outcome measure to be used for RCTs of complex interventions. IOM was developed using a narrative review, expert consultation and piloting with mental health service users (n = 20). The final version of IOM comprises two components: Goal Attainment (GA) and Personalized Primary Outcome (PPO). For GA, patients identify one relevant goal at baseline and rate its attainment at follow-up. For PPO, patients choose an outcome domain related to their goal from a pre-defined list at baseline, and complete a standardized questionnaire assessing the chosen outcome domain at baseline and follow-up. A feasibility study indicated that IOM had adequate completion (89%) and acceptability (96%) rates in a clinical sample (n = 84). IOM was then evaluated in a RCT (ISRCTN02507940). GA and PPO components were associated with each other and with the trial primary outcome. The use of the PPO component of IOM as the primary outcome could be considered in future RCTs. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.

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Pasha, Omrana; McClure, Elizabeth M; Wright, Linda L; Saleem, Sarah; Goudar, Shivaprasad S; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A; Derman, Richard J; Hibberd, Patricia L; Liechty, Edward K; Krebs, Nancy; Hambidge, K Michael; Buekens, Pierre; Moore, Janet; Jobe, Alan H; Koso-Thomas, Marion; Wallace, Dennis D; Stalls, Suzanne; Goldenberg, Robert L

2013-10-03

Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training

Outcomes in childhood following therapeutic hypothermia for neonatal hypoxic-ischemic encephalopathy (HIE).

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Natarajan, Girija; Pappas, Athina; Shankaran, Seetha

2016-12-01

In this article, we review the childhood outcomes of neonates with birth depression and/or hypoxic-ischemic encephalopathy. The outcomes of these children prior to the era of hypothermia for neuroprotection will first be summarized, followed by discussion of results from randomized controlled trials of therapeutic hypothermia for neonatal hypoxic-ischemic encephalopathy. The predictors of outcome in childhood following neonatal HIE using clinical and imaging biomarkers following hypothermia therapy will be described. Copyright © 2016 Elsevier Inc. All rights reserved.

To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial.

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Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark

2017-08-07

Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes

Role of nutrition in pre-eclampsia and eclampsia cases, a case control study

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Punyatoya Bej

2014-12-01

Full Text Available Background: Preeclampsia and eclampsia during pregnancy contribute to maternal and fetal morbidity as well as mortality. The identification of the role of maternal nutrition during pregnancy will help in reducing morbidity and mortality. Aims & Objective: The objective of this study is to find out the role of nutrition, in the form of total calorie, protein, fruits, iron, folic acid and calcium intake in the development of preeclampsia and eclampsia among pregnant women in a tertiary level hospital. Material Methods: After ethical approval and informed consent, 122 women who delivered beyond 22 weeks of gestation and diagnosed as preeclampsia or eclampsia were selected. Simultaneously, 122 controls with no diagnosis of preeclampsia or eclampsia were selected from the post natal ward. Cases and controls were administered the same pre-tested questionnaire containing questions related to food and micronutrient intake by cases and control. Results: Logistic regression was applied in the statistical analysis. The factors that were found to be significant predictors of risk for development of preeclampsia and eclampsia were higher calorie intake (adjusted Odds Ratio (OR 14.12 [6.41-43.23] P < 0.001, less protein intake (adjusted OR 3.87 [1.97-8.01] P < 0.001 during pregnancy. Fruits intake in both cases and controls were similar. 77.9% of cases and 84.4% of controls had taken iron tablets during their antenatal period. 75.4% of cases and 82.8% of controls had taken calcium tablets during their antenatal period. Iron and calcium intake is not significantly associated with development of preeclampsia and eclampsia. Conclusion: Higher calorie intake and less protein intake during pregnancy were associated with development of preeclampsia and eclampsia. Fruits intake, iron and calcium intake were not associated with development of preeclampsia and eclampsia

Maternal, Fetal, and Neonatal Outcomes in Pregnant Dengue Patients in Mexico

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Carlos Machain-Williams

2018-01-01

Full Text Available To increase our understanding of the consequences of dengue virus infection during pregnancy, a retrospective analysis was performed on the medical records of all completed pregnancies (live births and pregnancy losses at nine public hospitals in the Gulf of Mexico from January to October 2013. Eighty-two patients developed clinical, laboratory-confirmed dengue virus infections while pregnant. Of these, 54 (65.9% patients were diagnosed with dengue without warning signs, 15 (18.3% patients were diagnosed with dengue with warning signs, and 13 (15.9% patients had severe dengue. Five (38.5% patients with severe dengue experienced fetal distress and underwent emergency cesarean sections. Four patients delivered apparently healthy infants of normal birthweight while the remaining patient delivered a premature infant of low birthweight. Patients died of multiple organ failure during or within 10 days of the procedure. Severe dengue was also associated with obstetric hemorrhage (30.8%, four cases, preeclampsia (15.4%, two cases, and eclampsia (7.7%, one case. These complications were less common or absent in patients in the other two disease categories. Additionally, nonsevere dengue was not associated with maternal mortality, fetal distress, or adverse neonatal outcomes. In summary, the study provides evidence that severe dengue during pregnancy is associated with a high rate of fetal distress, cesarean delivery, and maternal mortality.

Meta-Analysis of Maternal and Neonatal Outcomes Associated with the Use of Insulin Glargine versus NPH Insulin during Pregnancy

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Jacques Lepercq

2012-01-01

Full Text Available As glargine, an analog of human insulin, is increasingly used during pregnancy, a meta-analysis assessed its safety in this population. A systematic literature search identified studies of gestational or pregestational diabetes comparing use of insulin glargine with human NPH insulin, with at least 15 women in both arms. Data was extracted for maternal outcomes (weight at delivery, weight gain, 1st/3rd trimester HbA1c, severe hypoglycemia, gestation/new-onset hypertension, preeclampsia, and cesarean section and neonatal outcomes (congenital malformations, gestational age at delivery, birth weight, macrosomia, LGA, 5 minute Apgar score >7, NICU admissions, respiratory distress syndrome, neonatal hypoglycemia, and hyperbilirubinemia. Relative risk ratios and weighted mean differences were determined using a random effect model. Eight studies of women using glargine (331 or NPH (371 were analyzed. No significant differences in the efficacy and safety-related outcomes were found between glargine and NPH use during pregnancy.

The impact of maternal hypothyroidism during pregnancy on neonatal outcomes: a systematic review and meta-analysis.

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Hou, Jiatong; Yu, Ping; Zhu, Huijuan; Pan, Hui; Li, Naishi; Yang, Hongbo; Jiang, Yu; Wang, Linjie; Wang, Bo; Wang, Yanhong; You, Lili; Chen, Shi

2016-01-01

The effects of maternal hypothyroidism on neonatal outcomes were not definitely confirmed. We conduct a systematic review of the literatures on the impact of maternal hypothyroidism on neonatal outcomes. We searched Pubmed, Embase and the Cochrane Controlled Trials Register databases complemented by manual searches in article references without language restrictions published from 1946 to April 2015. Nine trials are included. For preterm birth in pregnancies of hypothyroidism women, there is an increased tendency (RR 1.18; 95% CI 0.99 to 1.40; p = 0.06). The same result is seen relating to the low birth weight (RR 1.31; 95% CI 1.00 to 1.72; p = 0.05). Regarding small for gestational age there is no significant increase. Children who were born from mothers with hypothyroidism during pregnancy have increased birth weight (MD 32.35, 95% CI 7.46 to 57.24; p = 0.01). The impact of maternal hypothyroidism shows a trend of reduced risk of large for gestational age (RR 1.17; 95% CI 0.99 to 1.38; p = 0.06). Our review suggests that mothers with hypothyroidism during pregnancy are more likely to give birth to children with higher birth weight or LGA, and L-T4 supplementation should be recommended. The risk of preterm birth and low birth weight also tends to be higher in children with hypothyroidism mothers.

Associations of Maternal Vitamin D Deficiency with Pregnancy and Neonatal Complications in Developing Countries: A Systematic Review

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Paige van der Pligt

2018-05-01

Full Text Available Pregnant women in Asia, the Middle East, Africa and Latin America are at risk of vitamin D deficiency (VDD and prevalence throughout these regions are among the highest, globally. Maternal VDD has been associated with increased risk of a number of adverse maternal and neonatal health outcomes, yet research from developing countries is limited. We assessed the associations of maternal VDD during pregnancy with adverse health outcomes by synthesizing the literature from observational studies conducted in developing countries. Six electronic databases were searched for English-language studies published between 2000 and 2017. Thirteen studies from seven countries were included in the review. Prevalence of VDD ranged from 51.3% to 100%. Six studies assessed both maternal and neonatal outcomes, four studies assessed only maternal outcomes and three studies assessed only neonatal outcomes. Ten studies showed at least one significant association between VDD and adverse maternal and/or neonatal health outcomes including pre-eclampsia (n = 3, gestational diabetes mellitus (n = 1, postpartum depression (n = 1, emergency cesarean section delivery (n = 1, low birth weight babies (n = 4, small for gestational age (n = 2, stunting (n = 1. However most of these studies (n = 6 also showed no association with multiple health outcomes. Vitamin D assessment methods, criteria applied to define VDD, season and trimester in which studies were conducted varied considerably across studies. In conclusion, this study highlights the need to improve maternal vitamin D status in developing countries in an effort to support best maternal and child health outcomes across these regions. Future research should focus on more unified approaches to vitamin D assessment and preventative approaches that may be embedded into already existing antenatal care settings.

HIMALAIA (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA): a randomized single-blind controlled trial of induced hypertension vs. no induced hypertension in the treatment of delayed cerebral ischemia after subarachnoid hemorrhage.

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Gathier, C S; van den Bergh, W M; Slooter, A J C

2014-04-01

Delayed cerebral ischemia (DCI) is a major complication after aneurysmal subarachnoid hemorrhage (SAH). One option to treat delayed cerebral ischemia is to use induced hypertension, but its efficacy on the eventual outcome has not been proven in a randomized clinical trial. This article describes the design of the HIMALAIA trial (Hypertension Induction in the Management of AneurysmaL subArachnoid haemorrhage with secondary IschaemiA), designed to assess the effectiveness of induced hypertension on neurological outcome in patients with DCI after SAH. To investigate whether induced hypertension improves the functional outcome in patients with delayed cerebral ischemia after SAH. The HIMALAIA trial is a multicenter, singe-blinded, randomized controlled trial in patients with DCI after a recent SAH. Eligible patients will be randomized to either induced hypertension (n = 120) or to no induced hypertension (n = 120). In selected centers, the efficacy of induced hypertension in augmenting cerebral blood flow will be measured by means of cerebral perfusion computerized tomography scanning. Follow-up assessments will be performed at 3 and 12 months after randomization by trial nurses who are blinded to the treatment allocation and management. We will include patients during five years. The primary outcome is the proportion of subarachnoid hemorrhage patients with delayed cerebral ischemia with poor outcome three-months after randomization, defined as a modified Rankin scale of more than 3. Secondary outcome measures are related to treatment failure, functional outcome, adverse events, and cerebral hemodynamics. The HIMALAIA trial is registered at clinicaltrials.gov under identifier NCT01613235. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Outcome reporting across randomised trials and observational studies evaluating treatments for Twin-Twin Transfusion Syndrome: a systematic review.

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Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma

2018-04-01

Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.

Up-skilling associate clinicians in Malawi in emergency obstetric, neonatal care and clinical leadership: the ETATMBA cluster randomised controlled trial.

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Ellard, David R; Chimwaza, Wanangwa; Davies, David; Simkiss, Doug; Kamwendo, Francis; Mhango, Chisale; Quenby, Siobhan; Kandala, Ngianga-Bakwin; O'Hare, Joseph Paul

2016-01-01

The ETATMBA (Enhancing Training And Technology for Mothers and Babies in Africa) project-trained associate clinicians (ACs/clinical officers) as advanced clinical leaders in emergency obstetric and neonatal care. This trial aimed to evaluate the impact of training on obstetric health outcomes in Malawi. A cluster randomised controlled trial with 14 districts of Malawi (8 intervention, 6 control) as units of randomisation. Intervention districts housed the 46 ACs who received the training programme. The primary outcome was district (health facility-based) perinatal mortality rates. Secondary outcomes included maternal mortality ratios, neonatal mortality rate, obstetric and birth variables. The study period was 2011-2013. Mortality rates/ratios were examined using an interrupted time series (ITS) to identify trends over time. The ITS reveals an improving trend in perinatal mortality across both groups, but better in the control group (intervention, effect -3.58, SE 2.65, CI (-9.85 to 2.69), p=0.20; control, effect -17.79, SE 6.83, CI (-33.95 to -1.64), p=0.03). Maternal mortality ratios are seen to have improved in intervention districts while worsening in the control districts (intervention, effect -38.11, SE 50.30, CI (-157.06 to 80.84), p=0.47; control, effect 11.55, SE 87.72, CI (-195.87 to 218.98), p=0.90). There was a 31% drop in neonatal mortality rate in intervention districts while in control districts, the rate rises by 2%. There are no significant differences in the other secondary outcomes. This is one of the first randomised studies looking at the effect of structured training on health outcomes in this setting. Notwithstanding a number of limitations, this study suggests that up-skilling this cadre is possible, and could impact positively on health outcomes. ISRCTN63294155; Results.

The Impact of maternal obesity and race/ethnicity on perinatal outcomes: Independent and joint effects.

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Snowden, Jonathan M; Mission, John F; Marshall, Nicole E; Quigley, Brian; Main, Elliott; Gilbert, William M; Chung, Judith H; Caughey, Aaron B

2016-07-01

Independent and joint impacts of maternal race/ethnicity and obesity on adverse birth outcomes, including pre-eclampsia, low birth weight, and macrosomia, were characterized. Retrospective cohort study of all 2007 California births was conducted using vital records and claims data. Maternal race/ethnicity and maternal body mass index (BMI) were the key exposures; their independent and joint impact on outcomes using regression models was analyzed. Racial/ethnic minority women of normal weight generally had higher risk as compared with white women of normal weight (e.g., African-American women, pre-eclampsia adjusted odds ratio [aOR] 1.60, 95% confidence interval [CI]: 1.48-1.74 vs. white women). However, elevated BMI did not usually confer additional risk (e.g., pre-eclampsia aOR comparing African-American women with excess weight with white women with excess weight, 1.17, 95% CI: 0.89-1.54). Obesity was a risk factor for low birth weight only among white women (excess weight aOR, 1.24, 95% CI: 1.04-1.49 vs. white women of normal weight) and not among racial/ethnic minority women (e.g., African-American women, 0.95, 95% CI: 0.83-1.08). These findings add nuance to our understanding of the interplay between maternal race/ethnicity, BMI, and perinatal outcomes. While the BMI/adverse outcome gradient appears weaker in racial/ethnic minority women, this reflects the overall risk increase in racial/ethnic minority women of all body sizes. © 2016 The Obesity Society.

PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES: study protocol for a randomised controlled trial

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de Jonge Peter

2011-06-01

Full Text Available Abstract Background There is ample evidence from observational prospective studies that maternal depression or anxiety during pregnancy is a risk factor for adverse psychosocial outcomes in the offspring. However, to date no previous study has demonstrated that treatment of depressive or anxious symptoms in pregnancy actually could prevent psychosocial problems in children. Preventing psychosocial problems in children will eventually bring down the huge public health burden of mental disease. The main objective of this study is to assess the effects of cognitive behavioural therapy in pregnant women with symptoms of anxiety or depression on the child's development as well as behavioural and emotional problems. In addition, we aim to study its effects on the child's development, maternal mental health, and neonatal outcomes, as well as the cost-effectiveness of cognitive behavioural therapy relative to usual care. Methods/design We will include 300 women with at least moderate levels of anxiety or depression at the end of the first trimester of pregnancy. By including 300 women we will be able to demonstrate effect sizes of 0.35 or over on the total problems scale of the child behavioural checklist 1.5-5 with alpha 5% and power (1-beta 80%. Women in the intervention arm are offered 10-14 individual cognitive behavioural therapy sessions, 6-10 sessions during pregnancy and 4-8 sessions after delivery (once a week. Women in the control group receive care as usual. Primary outcome is behavioural/emotional problems at 1.5 years of age as assessed by the total problems scale of the child behaviour checklist 1.5 - 5 years. Secondary outcomes will be mental, psychomotor and behavioural development of the child at age 18 months according to the Bayley scales, maternal anxiety and depression during pregnancy and postpartum, and neonatal outcomes such as birth weight, gestational age and Apgar score, health care consumption and general health status

The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

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Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

2014-02-01

To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

Partial HELLP Syndrome: maternal and perinatal outcome

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Joelcio Francisco Abbade

Full Text Available CONTEXT: HELLP syndrome is a severe complication of pregnancy characterized by hemolysis, elevated liver enzymes and low platelet count. Some pregnant women develop just one or two of the characteristics of this syndrome, which is termed Partial HELLP Syndrome (PHS. OBJECTIVE: The objective of this study was to evaluate the repercussions on maternal and perinatal outcomes among women that developed PHS and to compare these women with those whose gestational hypertension or preeclampsia did not show alterations for HELLP syndrome in laboratory tests. DESIGN: Observational, retrospective and analytical study. SETTING: Maternity Department of Hospital das Clínicas, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, Botucatu, São Paulo, Brazil. SAMPLE: Pregnant or post-delivery women who had a blood pressure elevation that was first detected after mid-pregnancy, with or without proteinuria, between January 1990 and December 1995. MAIN MEASUREMENTS: Analysis was made of maternal age, race, parity, hypertension classification, gestational age at the PHS diagnosis, alterations in laboratory tests for HELLP syndrome, time elapsed to discharge from hospital, maternal complications, mode of delivery, incidence of preterm birth, intrauterine growth restriction, stillborn and neonatal death. RESULTS: Three hundred and eighteen women were selected; forty-one women (12.9% had PHS and 277 of them (87.1% did not develop any of the alterations of the HELLP syndrome diagnosis. Preeclampsia was a more frequent type of hypertension in the PHS group than in the hypertension group. None of the women with isolated chronic hypertension developed PHS. The rate of cesarean delivery, eclampsia, and preterm delivery was significantly greater in the PHS group than in the hypertension group. CONCLUSION: We observed that aggressive procedures had been adopted for patients with PHS. These resulted in immediate interruption of pregnancy, with elevated cesarean

Old and new aspects in the pathophysiology of pre-eclampsia

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Federico Prefumo

2007-12-01

Full Text Available Pre-eclampsia is a condition affecting the feto-placental unit and the mother. Three to five percent of pregnancies are complicated by pre-eclampsia, a multisystem disorder characterized by hypertension and proteinuria that occurs after 20 weeks of pregnancy. Pre-eclampsia is associated with substantial risks. For the fetus, these include intrauterine growth restriction, death, and prematurity with attendant complications, whereas the mother is at risk for complications of widespread alterations in endothelial function such as seizures (eclampsia, renal failure, pulmonary edema, stroke, and death. The establishment of pathological uterine perfusion raises the problem of stage two. The problem at stage three describes pre-eclampsia as a syndrome with the global maternal endothelial damage as the central pathophysiological feature.\tIt has been suggested that the pathophysiology of pre-eclampsia can be thought of as a ‘three-stage problem’, where each stage generates one, so far unsolved problem. An impaired trophoblast invasion is thought to be the central factor (first step regarding the etiology of pre-eclampsia. An increased uterine artery Doppler findings (PI, RI, lower maternal serum PAPP-A and free ßhCG levels, ischaemia modified albumin (IMA may be associated with pre-eclampsia.

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

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Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

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Marleine Azar

Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

Less-tight versus tight control of hypertension in pregnancy.

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Magee, Laura A; von Dadelszen, Peter; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E; Menzies, Jennifer; Sanchez, Johanna; Singer, Joel; Gafni, Amiram; Gruslin, Andrée; Helewa, Michael; Hutton, Eileen; Lee, Shoo K; Lee, Terry; Logan, Alexander G; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G; Moutquin, Jean-Marie

2015-01-29

The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear. We performed an open, international, multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension, office diastolic blood pressure of 90 to 105 mm Hg (or 85 to 105 mm Hg if the woman was taking antihypertensive medications), and a live fetus. Women were randomly assigned to less-tight control (target diastolic blood pressure, 100 mm Hg) or tight control (target diastolic blood pressure, 85 mm Hg). The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days. The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge, whichever was later. Included in the analysis were 987 women; 74.6% had preexisting hypertension. The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control (31.4% and 30.7%, respectively; adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.77 to 1.35), as were the rates of serious maternal complications (3.7% and 2.0%, respectively; adjusted odds ratio, 1.74; 95% CI, 0.79 to 3.84), despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg (95% CI, 3.7 to 5.4). Severe hypertension (≥160/110 mm Hg) developed in 40.6% of the women in the less-tight-control group and 27.5% of the women in the tight-control group (Phypertension. (Funded by the Canadian Institutes of Health Research; CHIPS Current Controlled Trials number, ISRCTN71416914; ClinicalTrials.gov number, NCT01192412.).

Periodontal Disease: A Possible Risk-Factor for Adverse Pregnancy Outcome.

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Parihar, Anuj Singh; Katoch, Vartika; Rajguru, Sneha A; Rajpoot, Nami; Singh, Pinojj; Wakhle, Sonal

2015-07-01

Bacterial invasion in subgingival sites especially of gram-negative organisms are initiators for periodontal diseases. The periodontal pathogens with persistent inflammation lead to destruction of periodontium. In recent years, periodontal diseases have been associated with a number of systemic diseases such as rheumatoid arthritis, cardiovascular-disease, diabetes mellitus, chronic respiratory diseases and adverse pregnancy outcomes including pre-term low-birth weight (PLBW) and pre-eclampsia. The factors like low socio-economic status, mother's age, race, multiple births, tobacco and drug-abuse may be found to increase risk of adverse pregnancy outcome. However, the same are less correlated with PLBW cases. Even the invasion of both aerobic and anerobic may lead to inflammation of gastrointestinal tract and vagina hence contributing to PLBW. The biological mechanism involved between PLBW and Maternal periodontitis is the translocation of chemical mediators of inflammation. Pre-eclampsia is one of the commonest cause of both maternal and fetal morbidity as it is characterized by hypertension and hyperprotenuria. Improving periodontal health before or during pregnancy may prevent or reduce the occurrences of these adverse pregnancy outcomes and, therefore, reduce the maternal and perinatal morbidity and mortality. Hence, this article is an attempt to review the relationship between periodontal condition and altered pregnancy outcome.

Effect of maternal age on maternal and neonatal outcomes after assisted reproductive technology

DEFF Research Database (Denmark)

Wennberg, Anna Lena; Opdahl, Signe; Bergh, Christina

2016-01-01

weeks), low birth weight (LBW; mortality (≥28 weeks). Adjusted odds ratios (AORs) were calculated. Associations between maternal age and outcomes were analyzed. RESULT(S): The risk of placenta previa (AOR 4.11-6.05), cesarean delivery (AOR 1......OBJECTIVE: To compare the effect of maternal age on assisted reproductive technology (ART) and spontaneous conception (SC) pregnancies regarding maternal and neonatal complications. DESIGN: Nordic retrospective population-based cohort study. Data from national ART registries were cross.......18-1.50), PTB (AOR 1.23-2.19), and LBW (AOR 1.44-2.35) was significantly higher in ART than in SC pregnancies for most maternal ages. In both ART and SC pregnancies, the risk of HDP, placenta previa, cesarean delivery, PTB, LBW, and SGA changed significantly with age. The AORs for adverse neonatal outcomes...

Effect of metformin on maternal and fetal outcomes in obese pregnant women (EMPOWaR): a randomised, double-blind, placebo-controlled trial.

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Chiswick, Carolyn; Reynolds, Rebecca M; Denison, Fiona; Drake, Amanda J; Forbes, Shareen; Newby, David E; Walker, Brian R; Quenby, Siobhan; Wray, Susan; Weeks, Andrew; Lashen, Hany; Rodriguez, Aryelly; Murray, Gordon; Whyte, Sonia; Norman, Jane E

2015-10-01

Maternal obesity is associated with increased birthweight, and obesity and premature mortality in adult offspring. The mechanism by which maternal obesity leads to these outcomes is not well understood, but maternal hyperglycaemia and insulin resistance are both implicated. We aimed to establish whether the insulin sensitising drug metformin improves maternal and fetal outcomes in obese pregnant women without diabetes. We did this randomised, double-blind, placebo-controlled trial in antenatal clinics at 15 National Health Service hospitals in the UK. Pregnant women (aged ≥16 years) between 12 and 16 weeks' gestation who had a BMI of 30 kg/m(2) or more and normal glucose tolerance were randomly assigned (1:1), via a web-based computer-generated block randomisation procedure (block size of two to four), to receive oral metformin 500 mg (increasing to a maximum of 2500 mg) or matched placebo daily from between 12 and 16 weeks' gestation until delivery of the baby. Randomisation was stratified by study site and BMI band (30-39 vs ≥40 kg/m(2)). Participants, caregivers, and study personnel were masked to treatment assignment. The primary outcome was Z score corresponding to the gestational age, parity, and sex-standardised birthweight percentile of liveborn babies delivered at 24 weeks or more of gestation. We did analysis by modified intention to treat. This trial is registered, ISRCTN number 51279843. Between Feb 3, 2011, and Jan 16, 2014, inclusive, we randomly assigned 449 women to either placebo (n=223) or metformin (n=226), of whom 434 (97%) were included in the final modified intention-to-treat analysis. Mean birthweight at delivery was 3463 g (SD 660) in the placebo group and 3462 g (548) in the metformin group. The estimated effect size of metformin on the primary outcome was non-significant (adjusted mean difference -0·029, 95% CI -0·217 to 0·158; p=0·7597). The difference in the number of women reporting the combined adverse outcome of miscarriage

Effect of obesity on neonatal outcomes in pregnancies with preterm premature rupture of membranes.

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Faucett, Allison M; Metz, Torri D; DeWitt, Peter E; Gibbs, Ronald S

2016-02-01

Maternal obesity is associated with increased systemic inflammation and an increased risk of preterm premature rupture of membranes. There is an established association between an inflammatory intrauterine environment and adverse neonatal outcomes that is independent of gestational age and mediated by the fetal inflammatory response. It is unknown whether the maternal systemic inflammation that is present in obese women influences the intrauterine environment and predisposes the fetus to adverse neonatal outcomes after preterm premature rupture of membranes. The purpose of this study was to determine whether maternal obesity is associated with adverse neonatal outcomes in pregnancies that are complicated by preterm premature rupture of membranes. This was a secondary analysis of the Maternal-Fetal Medicine Units Network Randomized Clinical Trial on the Beneficial Effects of Antenatal Magnesium Sulfate. Women with singleton pregnancies that were affected by preterm premature rupture of membranes who delivered live-born infants between 24 + 0 and 33 + 6 weeks of gestation were included. An adverse neonatal outcome was defined as a composite outcome of neonatal death, severe necrotizing enterocolitis, respiratory distress syndrome, sepsis, or severe intraventricular hemorrhage. The rates of the composite outcome were compared between obese (body mass index, ≥30 kg/m(2)) and nonobese women. Multivariable logistic regression was used to evaluate the independent effect of obesity on neonatal outcomes. Magnesium sulfate administration, steroid administration, maternal diabetes mellitus, gestational age at delivery, indomethacin exposure, birthweight, and chorioamnionitis were all considered as possible covariates in the multivariable regression models. Three hundred twenty-five of the 1288 women (25.2%) who were included were obese, and 202 of these women (62.2%) had neonates with adverse outcomes. In univariable analysis, maternal prepregnancy obesity was associated

Maternal urinary tract infection: is it independently associated with adverse pregnancy outcome?

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Mazor-Dray, Efrat; Levy, Amalia; Schlaeffer, Francisc; Sheiner, Eyal

2009-02-01

This population-based study was aimed to determine whether there is an association between urinary tract infections (UTI) during pregnancy, among patients in whom antibiotic treatment was recommended, and maternal and perinatal outcome. A retrospective population-based study comparing all singleton pregnancies of patients with and without UTI was performed. Multiple logistic regression models were performed to control for confounders. Out of 199,093 deliveries, 2.3% (n = 4742) had UTI during pregnancy and delivery. Patients with UTI had significantly higher rates of intra-uterine growth restriction (IUGR), pre-eclampsia, caesarean deliveries (CD) and pre-term deliveries (either before 34 weeks or 37 weeks of gestation). Although controlling for possible confounders such as maternal age and parity, using multivariable analyses, the significant association between UTI and IUGR, pre-eclampsia, CD and preterm deliveries persisted. In contrast, no significant differences in 5-min Apgar scores less than 7 or perinatal mortality were noted between the groups (0.6% vs. 0.6%; p = 0.782, and 1.5% vs. 1.4%; p = 0.704, respectively). Maternal UTI is independently associated with pre-term delivery, pre-eclampsia, IUGR and CD. Nevertheless, it is not associated with increased rates of perinatal mortality compared with women without UTI.

Association of maternal periodontal health with adverse pregnancy outcome.

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Kumar, Ashok; Basra, Minu; Begum, Nargis; Rani, Vigya; Prasad, Sudha; Lamba, Arundeep Kaur; Verma, Mahesh; Agarwal, Sarita; Sharma, Shashi

2013-01-01

The present study aims to determine the association of periodontal disease (identified early in pregnancy) and adverse pregnancy outcomes in a North Indian population.   A total of 340 primigravida women, aged 20-35 years with single live pregnancy were recruited at 14-20 weeks period of gestation from the antenatal clinic. These women had undergone periodontal examination at time of recruitment. The pregnancy outcomes were recorded. Out of 340 primigravida women, 147 (43.23%) women had gingivitis and 61 (17.94%) women had periodontitis. Periodontitis was found to be significantly associated with pre-eclampsia, intrauterine growth restriction, preterm delivery, and low birthweight with odds ratios (95% confidence interval) of 7.48 (2.72-22.42), 3.35 (1.20-9.55), 2.72 (1.30-5.68) and 3.03 (1.53-5.97), respectively. The study shows a significant association between periodontitis (but not with gingivitis) and adverse pregnancy outcomes. Maternal periodontitis is associated with an increased risk of pre-eclampsia, intrauterine growth restriction, preterm delivery and low birthweight infants. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

Perinatal outcome after ultrasound diagnosis of anhydramnios at term.

LENUS (Irish Health Repository)

Visvalingam, G

2012-01-01

The aim was to assess the maternal and fetal outcome in women who had labour induced for anhydramnios after 37 completed weeks of gestation. A retrospective study was conducted at the Rotunda Hospital from 1 January 2003 to 31 December 2007. All women with anhydramnios at term were identified from a review of ViewPoint® (computer software for antenatal scans performed), hospital data and the labour ward register. All women with a history of previous lower segment caesarean section (LSCS), current significant medical illness such as diabetes, hypertension, pre-eclampsia or ruptured membranes were excluded because the aim of the study was to focus specifically on low risk pregnancies with an incidental diagnosis of anhydramnios after 37 weeks\\' gestation. The maternal and fetal outcome parameters reviewed included: maternal age, parity, gestation, method of induction, mode of delivery, Apgar score and the requirement for obstetric or neonatal intervention. This study showed that anhydramnios is associated with a 56.6% LSCS rate in primigravida and a 19.0% LSCS rate in multigravida. Our study did not show any significant neonatal morbidity and there were no cases of mortality.

Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates.

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Zhao, Gengli; Xu, Guobin; Zhou, Min; Jiang, Yaping; Richards, Blair; Clark, Katy M; Kaciroti, Niko; Georgieff, Michael K; Zhang, Zhixiang; Tardif, Twila; Li, Ming; Lozoff, Betsy

2015-08-01

Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status. The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status. Enrollment occurred June 2009 through December 2011 in Hebei, China. Women with uncomplicated singleton pregnancies at ≤20 wk gestation, aged ≥18 y, and with hemoglobin ≥100 g/L were randomly assigned 1:1 to receive daily iron (300 mg ferrous sulfate) or placebo + 0.40 mg folate from enrollment to birth. Iron status was assessed in maternal venous blood (at enrollment and at or near term) and cord blood. Primary outcomes were as follows: 1) maternal iron deficiency (ID) defined in 2 ways as serum ferritin (SF) iron (BI) anemia [ID + anemia (IDA); hemoglobin 118 μmol/mol). A total of 2371 women were randomly assigned, with outcomes for 1632 women or neonates (809 placebo/folate, 823 iron/folate; 1579 mother-newborn pairs, 37 mothers, 16 neonates). Most infants (97%) were born at term. At or near term, maternal hemoglobin was significantly higher (+5.56 g/L) for iron vs. placebo groups. Anemia risk was reduced (RR: 0.53; 95% CI: 0.43, 0.66), as were risks of ID (RR: 0.74; 95% CI: 0.69, 0.79 by SF; RR: 0.65; 95% CI: 0.59, 0.71 by BI) and IDA (RR: 0.49; 95% CI: 0.38, 0.62 by SF; RR: 0.51; 95% CI: 0.40, 0.65 by BI). Most women still had ID (66.8% by SF, 54.7% by BI). Adverse effects, all minor, were similar by group. There were no differences in cord blood iron measures; >45% of neonates in each group had ID. However, dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed (β per 10 capsules = 2.60, P iron supplementation reduced anemia, ID, and IDA in pregnant women in rural China, but most women and >45% of neonates had ID, regardless of supplementation. This trial was registered at clinicaltrials.gov as NCT02221752. © 2015 American Society for Nutrition.

Maternal and Neonatal Outcome in Mothers with Gestational Diabetes Mellitus.

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Prakash, G Thiruvikrama; Das, Ashok Kumar; Habeebullah, Syed; Bhat, Vishnu; Shamanna, Suryanarayana Bettadpura

2017-01-01

Gestational diabetes mellitus (GDM) is common and is accompanied with other comorbidities. Challenges to treatment exist at our institute as it serves women with low income. This study assessed the burden of comorbidities and the outcome of GDM. This was a prospective, observational study of women with gestational diabetes attending the obstetrics department from September 2012 to April 2014. GDM was diagnosed based on the International Association of Diabetes and Pregnancy Study Groups criteria. Medical comorbidities were noted, and lipid profile was done. All the women were followed up till delivery, and the complications were recorded. Age- and parity-matched pregnant women with normal oral glucose tolerance test were recruited as controls. One hundred and thirty-nine women were followed up till delivery. The average age was 28 years. Eighteen percent had bad obstetric history. The average body mass index was 28.8. Twenty-five percent had gestational hypertension (HTN), and 6.4% had chronic HTN. Thirty percent had hypothyroidism. 65% women received insulin. The glucose values were within the recommended range in 60% of the women. Maternal hypoglycemia occurred in 7 (5%) women. Forty-four percent of the women required cesarean section and 34% had complications either during pregnancy or labor. Three neonates had macrosomia. Twenty-six neonates (20%) required admission to the Neonatal Intensive Care Unit. Four neonates (3%) died. Newborns of mothers whose GDM optimally treated had less complications. Gestational diabetes is associated with HTN, hypothyroidism, obesity, and lipid abnormalities. The majority of women required insulin for treatment and optimal control of blood glucose resulted in lower neonatal complications.

The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

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Fottrell Edward F

2011-09-01

Full Text Available Abstract Background Progress on neonatal survival has been slow in most countries. While there is evidence on what works to reduce newborn mortality, there is limited knowledge on how to deliver interventions effectively when health systems are weak. Cluster randomized trials have shown strong reductions in neonatal mortality using community mobilisation with women's groups in rural Nepal and India. A similar trial in Bangladesh showed no impact. A main hypothesis is that this negative finding is due to the much lower coverage of women's groups in the intervention population in Bangladesh compared to India and Nepal. For evidence-based policy making it is important to examine if women's group coverage is a main determinant of their impact. The study aims to test the effect on newborn and maternal health outcomes of a participatory women's group intervention with a high population coverage of women's groups. Methods A cluster randomised trial of a participatory women's group intervention will be conducted in 3 districts of rural Bangladesh. As we aim to study a women's group intervention with high population coverage, the same 9 intervention and 9 control unions will be used as in the 2005-2007 trial. These had been randomly allocated using the districts as strata. To increase coverage, 648 new groups were formed in addition to the 162 existing groups that were part of the previous trial. An open cohort of women who are permanent residents in the union in which their delivery or death was identified, is enrolled. Women and their newborns are included after birth, or, if a woman dies during pregnancy, after her death. Excluded are women who are temporary residents in the union in which their birth or death was identified. The primary outcome is neonatal mortality in the last 24 months of the study. A low cost surveillance system will be used to record all birth outcomes and deaths to women of reproductive age in the study population. Data on home

A controlled trial of the effect of aromatherapy on birth outcomes using "Rose essential oil" inhalation and foot bath

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Masoomeh Kheirkhah

2013-12-01

Full Text Available Background and aim: Aromatherapy is the art and science of using essential oils extracted from aromatic plants, and is concerned with natural balance, coordination and promotion of health. This study was designed to determine the effect of "rose (Rosa damascena essential oil" inhalation and foot bath on the improvement of maternal and neonatal health outcomes. Material and methods: This study was a randomized clinical trial, conducted on 80 primiparous women in Shahid Akbar Abadi Maternity Hospital, Tehran, Iran. Subjects were randomly assigned to aromatherapy and control groups. Aromatherapy group received methods of inhalation and foot bath with rose essential oil for 10 minutes at the beginning of the active phase and then at the onset of the transitional phase of labor. Control group received the routine care of the delivery room. The measured variables in this study included episiotomy in the second stages of labor, Apgar score, admission to neonatal intensive care unit (NICU, and maternal satisfaction with the administration of pain relievers. Statistical analysis of the extracted data was performed using SPSS version 16 with Chi-square and t student test. Results: Two groups were significantly different in terms of the second stage of labor duration (P

Methods of pushing during vaginal delivery and pelvic floor and perineal outcomes: a review.

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de Tayrac, Renaud; Letouzey, Vincent

2016-12-01

Over the past 20 years, several randomized studies have compared Valsalva and spontaneous pushing techniques during vaginal delivery. This review summarizes current medical knowledge concerning their maternal and fetal consequences, focusing on pelvic and perineal outcomes. We selected nine randomized controlled trials comparing Valsalva and spontaneous pushing, and a secondary analysis of a randomized controlled trial comparing different methods of perineal protection. Two trials showed that spontaneous pushing reduces the risk of perineal tears, but no firm conclusions can be drawn given the heterogeneity and inconsistent results of these studies. Conflicting results have been reported regarding the duration of the second stage of labor. Pushing technique does not seem to affect episiotomy, instrumental delivery or cesarean rates. Maternal satisfaction seems to be better after spontaneous pushing. Spontaneous pushing appears to have no adverse effects on neonatal well being, and one study showed a significant improvement in prenatal fetal parameters during the expulsive phase. Valsalva and spontaneous pushing techniques currently appear comparable in terms of duration, pelvic floor, perineal, and neonatal outcomes. In the absence of strong evidence in favor of either technique, the decision should be guided by patient preference and the clinical situation. Additional, well-designed randomized controlled trials are required.

Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

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Mackillop, Lucy; Hirst, Jane Elizabeth; Bartlett, Katy Jane; Birks, Jacqueline Susan; Clifton, Lei; Farmer, Andrew J; Gibson, Oliver; Kenworthy, Yvonne; Levy, Jonathan Cummings; Loerup, Lise; Rivero-Arias, Oliver; Ming, Wai-Kit; Velardo, Carmelo; Tarassenko, Lionel

2018-03-20

Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean

Effect of the number of Ramadan fasting days on maternal and neonatal outcomes

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Hassan Boskabadi

2014-09-01

Full Text Available Introduction: Gynecologists and perinatologists are left with many unanswered questions and concerns regarding fasting during pregnancy and its effects on maternal and neonatal health. The current study was conducted to investigate the correlation between the number of Ramadan fasting days and pregnancy outcomes. Materials & Methods: In this descriptive, analytical study, 641 newborns, whose mothers had fasting experience during pregnancy, were enrolled and allocated to three groups, based on the number of maternal fasting days during pregnancy (group A: ≤10 days, group B: 11-20 days, and group C: 21-30 days. Demographic and anthropometric data of neonates and mothers were recorded. Descriptive statistics, Chi-square, and non-parametric tests were performed for data analysis. Results: No statistically significant difference was found in maternal weight (during the last month of pregnancy, neonatal height, incidence of pre-term labor, or neonatal congenital abnormality in the three groups. Increased number of fasting days was not correlated with decreased neonatal head circumference or weight, while 1- and 5-minute Apgar scores significantly improved (P

Maternal and neonatal outcomes for pregnancies before and after gastric bypass surgery

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Adams, TD; Hammoud, AO; Davidson, LE; Laferrère, B; Fraser, A; Stanford, JB; Hashibe, M; Greenwood, JLJ; Kim, J; Taylor, D; Watson, AJ; Smith, KR; McKinlay, R; Simper, SC; Smith, SC; Hunt, SC

2016-01-01

BACKGROUND Interaction between maternal obesity, intrauterine environment and adverse clinical outcomes of newborns has been described. METHODS Using statewide birth certificate data, this retrospective, matched-control cohort study compared paired birth weights and complications of infants born to women before and after Roux-en-Y gastric bypass surgery (RYGB) and to matched obese non-operated women in several different groups. Women who had given birth to a child before and after RYGB (group 1; n = 295 matches) and women with pregnancies after RYGB (group 2; n = 764 matches) were matched to non-operated women based on age, body mass index (BMI) prior to both pregnancy and RYGB, mother’s race, year of mother/s birth, date of infant births and birth order. In addition, birth weights of 13 143 live births before and/or after RYGB of their mothers (n = 5819) were compared (group 3). RESULTS Odds ratios (ORs) for having a large-for-gestational-age (LGA) neonate were significantly less after RYGB than for non-surgical mothers: ORs for groups 1 and 2 were 0.19 (0.08–0.38) and 0.33 (0.21–0.51), respectively. In contrast, ORs in all three groups for risk of having a small for gestational age (SGA) neonate were greater for RYGB mothers compared to non-surgical mothers (ORs were 2.16 (1.00–5.04); 2.16 (1.43–3.32); and 2.25 (1.89–2.69), respectively). Neonatal complications were not different for group 1 RYGB and non-surgical women for the first pregnancy following RYGB. Pregnancy-induced hypertension and gestational diabetes were significantly lower for the first pregnancy of mothers following RYGB compared to matched pregnancies of non-surgical mothers. CONCLUSION Women who had undergone RYGB not only had lower risk for having an LGA neonate compared to BMI-matched mothers, but also had significantly higher risk for delivering an SGA neonate following RYGB. RYGB women were less likely than non-operated women to have pregnancy-related hypertension and diabetes

Prediction of pre-eclampsia by maternal characteristics : A case-controlled validation study of a Bayesian network model for risk identification of pre-eclampsia

NARCIS (Netherlands)

Meurs, van A.; Velikova, M.; van der Hout, Beatrijs; Vermeulen-Giovagnoli, Barbara; Oei, S G

2014-01-01

Brief Introduction: Pre-eclampsia (PE) is worldwide a leading and rising cause of maternal and perinatal morbidity and mortality. As PE remains a serious and poorly understood complication of pregnancy, it is necessary to recognize the disease before it threatens the survival of mother and fetus. A

[The Impact of Late Umbilical Cord Clamping on Neonatal Jaundice and Postpartum Hemorrhage: A Randomized Controlled Trail].

Science.gov (United States)

Chien, Pei-Chun; Yang, Cherng-Chia; Gau, Meei-Ling; Liu, Chieh-Yu; Lee, Tzu-Ying

2015-08-01

The current evidence supports the clinical benefits of late umbilical cord clamping. These benefits include increased blood volume and total body iron. Furthermore, delayed cord clamping facilitates the transplantation of stem cells, which helps the development of infant bodily systems. However, due to concerns related to postpartum hemorrhaging and neonate jaundice, most maternity units still clamp the cord immediately after a child is born. This study investigates the impact of delaying cord clamping on neonatal jaundice and postpartum hemorrhage. A randomized, controlled trial was conducted at a regional teaching hospital in northern Taiwan. One hundred and five healthy nulliparous women at 36 weeks of pregnancy were included and allocated randomly to the experiment group (n=44) and the control group (n=61). Participants in the experiment group received delayed cord clamping (DCC) at 3 minutes after delivery. Participants in the control group received early cord clamping (ECC) at around 1 minute after delivery. Clinical measures of the outcomes were measured by the infant transcutaneous bilirubin levels (TcB) and postpartum hemorrhage at birth. A structured questionnaire and biophysical measures were used to collect data on participant demographics, obstetrical information, maternal blood loss at birth, neonate weight and TcB level at hospitalization, and whether or not the infant received phototherapy at 4-7 days postpartum. Overall, there was no significant difference between the two groups in terms of neonatal jaundice, maternal hemorrhage at birth, and phototherapy rates at time of hospitalization and at 4-7 days postpartum. The findings of the present study support that late umbilical cord clamping does not increase the risk of maternal postpartum hemorrhaging or neonate jaundice. Thus, we suggest that clinicians inform clients during prenatal classes of the benefits of delayed cord clamping and also use current, evidence-based knowledge to dispel client

Effect of hypertensive disorders during pregnancy on neonatal outcomes and umbilical artery flow

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Dong-mei ZHENG

2013-09-01

Full Text Available Objective　To observe the effect of hypertensive disorders during pregnancy (HDP on neonatal outcomes and umbilical artery flow. Methods　A prospective cohort study method was employed, and 60 pregnant women met the HDP diagnostic criteria (HDP group, aged 31.2±6.0 years, gestation time 251.0±9.0d, hospitalized from Sep. 2011 to May. 2012, and delivered live-born infants and 63 pregnant women with normal blood pressure and without medical or surgical ailments (control group, aged 30.2±2.8 years, gestation time 251.9±7.7d, hospitalized in the the same period, and had live birth were involved in present study. The indexes of umbilical artery blood flow were measured, the adverse neonatal outcomes (neonatal asphyxia, low birth weight babies and premature labor were recorded, and the correlation was analyzed between the adverse neonatal outcomes and the indexes of umbilical artery blood flow. Results　The incidence of adverse neonatal outcomes (neonatal asphyxia, low birth weight newborns and premature labor was higher in HDP group (58.3%, 45.0% and 53.3%, respectively than in control group (6.3%, 3.2% and 3.2%, respectively, P<0.05. The results of umbilical artery blood flow indexes, including pulsatility index (PI, resistance index (RI and systolic/diastolic ratio (S/D in HDP group (0.897±0.176, 0.588±0.701 and 2.655±0.346, respectively were significantly higher than in control group (0.741±0.123, 0.525±0.650 and 2.120±0.364, respectively, P<0.05. The indexes of umbilical artery blood flow (PI, RI and S/D in newborns with adverse outcomes were significantly higher than in those newborn without adverse outcomes. Multivariate logistic regression revealed a positive correlation between RI and adverse neonatal outcomes. Conclusions　The indexes of umbilical artery blood flow appear to be abnormal in pregnant women with HDP, and adverse neonatal conditions (neonatal asphyxia, low birth weight newborns and premature labor are prone to

Longitudinal Impact of a Randomized Clinical Trial to Improve Family Function, Reduce Maternal Stress and Improve Child Outcomes in Families of Children with ADHD.

Science.gov (United States)

Churchill, Shervin S; Leo, Michael C; Brennan, Eileen M; Sellmaier, Claudia; Kendall, Judy; Houck, Gail M

2018-02-23

Objective Evaluate the efficacy of a 12 month nursing case-management intervention over a period of 18 months, 6 months after the end of intervention, for families of children attention deficit hyperactivity disorder (ADHD). Methods Mother and child dyads were enrolled to participate in a randomized controlled clinical trial. Children were 4-18 years old. Data were collected at baseline, 6, 12, and 18 months or 6 months after the termination of direct intervention. Longitudinal analyses, using generalized estimating equations, were conducted to assess change in study outcomes relating to family function, maternal stress, and child behavior over the 18 month period. Results Compared to control families, some family function outcomes were moderately improved in the intervention group. In particular, intervention families demonstrated substantial improvement in implementing family behavior controls (p value = 0.038) and improvement in family satisfaction (not statistically significant p = 0.062). Although there was improvement in the overall family function measure there was not a statistically significant difference between groups. Maternal stress and child behavior outcomes were not significantly different between control and intervention groups by the end of the intervention. Conclusions for Practice Addressing ADHD is complex and requires the assessment of comorbidities that might exacerbate negative behavior. Our findings support the latest American Academy of Pediatrics guidelines to use behavioral therapy as the first line of treatment in young children. Nursing case-management interventions that provide direct family education and improve family function, especially with respect to providing structure and behavior control, may complement and facilitate behavioral therapy for treatment of ADHD and improving child behavior.

The Impact of Teenage Pregnancy on Maternal and Perinatal Outcome

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Chaitra Ramachandra

2016-05-01

Full Text Available To study the impact of teenage pregnancy on maternal and perinatal outcome. This is a randomized prospective clinical study carried out in the Obstetrics and Gynaecology department, BGS Global Medical College, over a period of one year from January 2015 to December 2015. In study group (Group A included a total of 200 primigravid teenage mothers(age <20 years and the control group included 200 primigavid adult mothers (20- 30years of age . The maternal status, labour progress, delivery characteristics and neonatal outcomes were reviewed and analysed. Proportion of mothers in the study group who delivered vaginally was 61.5% compared to 80.5% in the control group. Instrumental delivery rate, emergency LSCS and elective LSCS rates were higher in the study group (teenage pregnancy compared to the control group. (9.5% Vs 5%, 17% Vs 9.5%, 12% Vs 5% respectively. Anaemia, Premature Rupture of Membranes, Oligohydraminos, Post partum Haemorrhage was found to be higher among teenage mothers when compared to adult mothers. PIH, polyhydraminos were found to be higher in control group than in the study group. In regard to adverse perinatal outcomes, higher risks of intra uterine growth restriction, preterm births, stillbirths, low APGAR scores, NICU admission were higher were higher in the study group compared to the control group. In this study, we found that women with teenage pregnancies were at increased risk for adverse pregnancy outcomes in regard to maternal, foetal and neonatal complications as compared with adult control mothers.

Maternal periodontal disease, pregnancy, and neonatal outcomes.

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Dasanayake, Ananda P; Gennaro, Susan; Hendricks-Muñoz, Karen D; Chhun, Nok

2008-01-01

The purpose of this article is to review the current literature on the association between maternal periodontal disease and poor pregnancy and neonatal outcomes and outline the role nurses can play in improving the oral health of pregnant women. Maternal periodontal disease is linked to preterm birth, low birthweight, and preterm low birthweight, but treatment of periodontal disease during pregnancy has been shown to be safe and effective. Nurses, nurse practitioners, and nurse-midwives are in a position to educate pregnant women on the benefits of good oral health and identify and refer women who are in need of dental care for treatment.

Effect of thrombocytopenia on mode of analgesia/anesthesia and maternal and neonatal outcomes.

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Dikman, Daniel; Elstein, Deborah; Levi, Gal Schtrechman; Granovsky-Grisaru, Sorina; Samueloff, Arnon; Gozal, Yaacov; Ioscovich, Alexander

2014-04-01

The purpose was to correlate the use of regional analgesia/anasthesia among women with different degrees of thrombocytopenia relative to women with normal platelet counts, and note maternal and neonatal outcome, and mode of delivery. A case-control paradigm was developed based on women who delivered during 2007-2011 with platelet counts ≤80 000/mm(3). For each woman in this "severe" thrombocytopenic group, an age- and parity-matched control was found who delivered a singleton within the same year but whose platelets were either 81 000-150 000/mm(3) ("moderate" thrombocytopenia) or ≥151 000/mm(3) (normal platelet counts). 168 women were identified for each group; mean maternal age (28.4 years), mean gravidity (4.3), mean parity (3.7), mean gestational age (39.2 weeks) and mean birth weight (3283 g) were comparable. However, only in the severe thrombocytopenic women were there very early preterm deliveries, lowest birth weight, lowest Apgar scores, the greatest number with serious post-partum hemorrhage (>500 ml); use of regional analgesia/anesthesia was lowest, and percent cesarean sections highest. This study highlights potential for adverse maternal outcome of post-partum hemorrhage and adverse neonatal outcomes of prematurity, low birth weight, and low Apgar scores (but not neonatal death), and limited regional analgesia/anesthesia in women who present at delivery with severe (≤80 000/mm(3)) thrombocytopenia.

Maternal and neonatal outcome in mothers with gestational diabetes mellitus

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G Thiruvikrama Prakash

2017-01-01

Full Text Available Introduction: Gestational diabetes mellitus (GDM is common and is accompanied with other comorbidities. Challenges to treatment exist at our institute as it serves women with low income. This study assessed the burden of comorbidities and the outcome of GDM. Methods: This was a prospective, observational study of women with gestational diabetes attending the obstetrics department from September 2012 to April 2014. GDM was diagnosed based on the International Association of Diabetes and Pregnancy Study Groups criteria. Medical comorbidities were noted, and lipid profile was done. All the women were followed up till delivery, and the complications were recorded. Age- and parity-matched pregnant women with normal oral glucose tolerance test were recruited as controls. Results: One hundred and thirty-nine women were followed up till delivery. The average age was 28 years. Eighteen percent had bad obstetric history. The average body mass index was 28.8. Twenty-five percent had gestational hypertension (HTN, and 6.4% had chronic HTN. Thirty percent had hypothyroidism. 65% women received insulin. The glucose values were within the recommended range in 60% of the women. Maternal hypoglycemia occurred in 7 (5% women. Forty-four percent of the women required cesarean section and 34% had complications either during pregnancy or labor. Three neonates had macrosomia. Twenty-six neonates (20% required admission to the Neonatal Intensive Care Unit. Four neonates (3% died. Newborns of mothers whose GDM optimally treated had less complications. Conclusion: Gestational diabetes is associated with HTN, hypothyroidism, obesity, and lipid abnormalities. The majority of women required insulin for treatment and optimal control of blood glucose resulted in lower neonatal complications.

Assessing the Effect of mHealth Interventions in Improving Maternal and Neonatal Care in Low- and Middle-Income Countries: A Systematic Review.

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Sondaal, Stephanie Felicie Victoria; Browne, Joyce Linda; Amoakoh-Coleman, Mary; Borgstein, Alexander; Miltenburg, Andrea Solnes; Verwijs, Mirjam; Klipstein-Grobusch, Kerstin

2016-01-01

Maternal and neonatal mortality remains high in many low- and middle-income countries (LMIC). Availability and use of mobile phones is increasing rapidly with 90% of persons in developing countries having a mobile-cellular subscription. Mobile health (mHealth) interventions have been proposed as effective solutions to improve maternal and neonatal health. This systematic review assessed the effect of mHealth interventions that support pregnant women during the antenatal, birth and postnatal period in LMIC. The review was registered with Prospero (CRD42014010292). Six databases were searched from June 2014-April 2015, accompanied by grey literature search using pre-defined search terms linked to pregnant women in LMIC and mHealth. Quality of articles was assessed with an adapted Cochrane Risk of Bias Tool. Because of heterogeneity in outcomes, settings and study designs a narrative synthesis of quantitative results of intervention studies on maternal outcomes, neonatal outcomes, service utilization, and healthy pregnancy education was conducted. Qualitative and quantitative results were synthesized with a strengths, weaknesses, opportunities, and threats analysis. In total, 3777 articles were found, of which 27 studies were included: twelve intervention studies and fifteen descriptive studies. mHealth interventions targeted at pregnant women increased maternal and neonatal service utilization shown through increased antenatal care attendance, facility-service utilization, skilled attendance at birth, and vaccination rates. Few articles assessed the effect on maternal or neonatal health outcomes, with inconsistent results. mHealth interventions may be effective solutions to improve maternal and neonatal service utilization. Further studies assessing mHealth's impact on maternal and neonatal outcomes are recommended. The emerging trend of strong experimental research designs with randomized controlled trials, combined with feasibility research, government involvement

Assessing the Effect of mHealth Interventions in Improving Maternal and Neonatal Care in Low- and Middle-Income Countries: A Systematic Review.

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Stephanie Felicie Victoria Sondaal

Full Text Available Maternal and neonatal mortality remains high in many low- and middle-income countries (LMIC. Availability and use of mobile phones is increasing rapidly with 90% of persons in developing countries having a mobile-cellular subscription. Mobile health (mHealth interventions have been proposed as effective solutions to improve maternal and neonatal health. This systematic review assessed the effect of mHealth interventions that support pregnant women during the antenatal, birth and postnatal period in LMIC.The review was registered with Prospero (CRD42014010292. Six databases were searched from June 2014-April 2015, accompanied by grey literature search using pre-defined search terms linked to pregnant women in LMIC and mHealth. Quality of articles was assessed with an adapted Cochrane Risk of Bias Tool. Because of heterogeneity in outcomes, settings and study designs a narrative synthesis of quantitative results of intervention studies on maternal outcomes, neonatal outcomes, service utilization, and healthy pregnancy education was conducted. Qualitative and quantitative results were synthesized with a strengths, weaknesses, opportunities, and threats analysis.In total, 3777 articles were found, of which 27 studies were included: twelve intervention studies and fifteen descriptive studies. mHealth interventions targeted at pregnant women increased maternal and neonatal service utilization shown through increased antenatal care attendance, facility-service utilization, skilled attendance at birth, and vaccination rates. Few articles assessed the effect on maternal or neonatal health outcomes, with inconsistent results.mHealth interventions may be effective solutions to improve maternal and neonatal service utilization. Further studies assessing mHealth's impact on maternal and neonatal outcomes are recommended. The emerging trend of strong experimental research designs with randomized controlled trials, combined with feasibility research

[Perinatal result with conservative treatment in preeclampsia-eclampsia].

Science.gov (United States)

Briones-Garduño, Jesús Carlos; de León-Ponce, Manuel Díaz; González-Vargas, Angel; Briones-Vega, Carlos Gabriel

2003-01-01

Conservative treatment in severe preeclampsia has been documented by several authors citing significant improvement in neonatal outcome lacking a significant increase in maternal complications. Our objective was to inform of our preliminary results using protocolized conservative management in women with preeclampsia-eclampsia, favoring better neonate conditions. We included 34 patients with average age of 28.2 years with documented severe preeclampsia-eclampsia complicating a 36-weeks or less pregnancy, admitted in the obstetric intensive care unit (OICU) between October 2001 and February 2002. Patients received protocolized management consisting of intravascular colume expansion, anti-hypertensive control, target organ protection, monitoring, and clinical observation. We considered conservative management as a 24 or more period offered to patients with satisfactory response to medical treatment and no evidence of binomial compromise. Of our group, 85% corresponded to severe preeclampsia, 9% to eclampsia, 3% to imminence of eclampsia, and 3% to HELLP syndrome. Average stay in OICU was 5.5 days with 3.5 days average management before pregnancy was interrupted. These patients presented mean gestational age of 32.8 weeks during which we observed anemia, low platelets, D dimmer increments, MAP average of 112.8, PCOc 18.6, and BI 0.15. We obtained 36 live newborns of whom 12% four died, two were extremely immatures (510 g and 600 g, respectively); one 980-g newborn presented intraventricular hemorrhage, and a 1,450-g newborn had multiple organ failure. Conservative treatment in patients with severe preeclampsia-eclampsia is a feasible alternative in hospitals with an ICU. Conservative management can improve neonatal survival and prognosis in preterm newborns.

Low-Dose versus Standard-Dose Intravenous Immunoglobulin to Prevent Fetal Intracranial Hemorrhage in Fetal and Neonatal Alloimmune Thrombocytopenia: A Randomized Trial.

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Paridaans, Noortje P; Kamphuis, Marije M; Taune Wikman, Agneta; Tiblad, Eleonor; Van den Akker, Eline S; Lopriore, Enrico; Challis, Daniel; Westgren, Magnus; Oepkes, Dick

2015-01-01

Pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT) are commonly treated using weekly intravenous immunoglobulin (IVIG) at 1 g/kg maternal weight. IVIG is an expensive multidonor human blood product with dose-related side effects. Our aim was to evaluate the effectiveness of IVIG at a lower dose, i.e., 0.5 g/kg. This was a randomized controlled multicenter trial conducted in Sweden, the Netherlands and Australia. Pregnant women with human platelet antigen alloantibodies and an affected previous child without intracranial hemorrhage (ICH) were enrolled. The participants were randomized to IVIG at 0.5 or 1 g/kg per week. The analyses were per intention to treat. The primary outcome was fetal or neonatal ICH. Secondary outcomes were platelet count at birth, maternal and neonatal IgG levels, neonatal treatment and bleeding other than ICH. A total of 23 women were randomized into two groups (low dose: n = 12; standard dose: n = 11). The trial was stopped early due to poor recruitment. No ICH occurred. The median newborn platelet count was 81 × 10(9)/l (range 8-269) in the 0.5 g/kg group versus 110 × 10(9)/l (range 11-279) in the 1 g/kg group (p = 0.644). The risk of adverse outcomes in FNAIT pregnancies treated with IVIG at 0.5 g/kg is very low, similar to that using 1 g/kg, although our uncompleted trial lacked the power to conclusively prove the noninferiority of using the low dose.

Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems.

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Hofmeyr, G Justus; Lawrie, Theresa A; Atallah, Alvaro N; Duley, Lelia; Torloni, Maria R

2014-06-24

Pre-eclampsia and eclampsia are common causes of serious morbidity and death. Calcium supplementation may reduce the risk of pre-eclampsia, and may help to prevent preterm birth. To assess the effects of calcium supplementation during pregnancy on hypertensive disorders of pregnancy and related maternal and child outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (28 March 2013) and contacted study authors for more data where possible. We updated the search in May 2014 and added the results to the 'Awaiting Classification' section of the review. Randomised controlled trials (RCTs) comparing high-dose (at least 1 g daily of calcium) or low-dose calcium supplementation during pregnancy with placebo or no calcium. We assessed eligibility and trial quality, extracted and double-entered data. High-dose calcium supplementation (≥1 g/day)We included 14 studies in the review, however one study contributed no data. We included 13 high-quality studies in our meta-analyses (15,730 women). The average risk of high blood pressure (BP) was reduced with calcium supplementation compared with placebo (12 trials, 15,470 women: risk ratio (RR) 0.65, 95% confidence interval (CI) 0.53 to 0.81; I² = 74%). There was also a significant reduction in the risk of pre-eclampsia associated with calcium supplementation (13 trials, 15,730 women: RR 0.45, 95% CI 0.31 to 0.65; I² = 70%). The effect was greatest for women with low calcium diets (eight trials, 10,678 women: average RR 0.36, 95% CI 0.20 to 0.65; I² = 76%) and women at high risk of pre-eclampsia (five trials, 587 women: average RR 0.22, 95% CI 0.12 to 0.42; I² = 0%). These data should be interpreted with caution because of the possibility of small-study effect or publication bias.The composite outcome maternal death or serious morbidity was reduced (four trials, 9732 women; RR 0.80, 95% CI 0.65 to 0.97; I² = 0%). Maternal deaths were not significantly different (one trial of 8312 women: calcium

Maternal and neonatal health outcomes following assisted reproduction.

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Farhi, A; Reichman, B; Boyko, V; Hourvitz, A; Ron-El, R; Lerner-Geva, L

2013-05-01

This study assessed the risk for maternal complications in women and neonatal outcomes in children conceived following assisted reproductive treatment as compared with spontaneously conception and also separately evaluated conventional IVF and intracytoplasmic sperm injection (ICSI). The prospective cohort included 1161 women with singleton pregnancies: 561 who conceived following assisted reproduction (223 following IVF and 338 following ICSI) and 600 who conceived spontaneously. No differences were observed in pregnancy complications (including spontaneous abortion, pregnancy-induced hypertension, gestational diabetes and Caesarean delivery) except for significantly increased risk for excess vaginal bleeding in assisted reproduction pregnancies (21.4% versus 12.9%; OR 1.67, 95% CI 1.18-2.37), which was prominent in women who reported polycystic ovary syndrome. Neonates born following assisted reproduction had increased risk for prematurity (10.6% versus 5.3%; OR 1.72, 95% CI 1.04-2.87), and IVF, but not ICSI, was associated with significantly increased risk for prematurity (OR 2.36, 95% CI 1.28-4.37) and low birthweight (OR 1.89, 95% CI 1.03-3.46). In conclusion, this study observed only an increased risk for excess vaginal bleeding as a pregnancy-associated complication in singleton pregnancies following assisted compared with spontaneous conception. However, singleton neonates born following IVF, but not ICSI, were at increased risk for prematurity. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

The CHIPS Randomized Controlled Trial (Control of Hypertension in Pregnancy Study): Is Severe Hypertension Just an Elevated Blood Pressure?

NARCIS (Netherlands)

Magee, Laura A.; von Dadelszen, Peter; Singer, Joel; Lee, Terry; Rey, Evelyne; Ross, Susan; Asztalos, Elizabeth; Murphy, Kellie E.; Menzies, Jennifer; Sanchez, Johanna; Gafni, Amiram; Helewa, Michael; Hutton, Eileen; Koren, Gideon; Lee, Shoo K.; Logan, Alexander G.; Ganzevoort, Wessel; Welch, Ross; Thornton, Jim G.; Moutquin, Jean-Marie

2016-01-01

To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of less tight (target diastolic blood pressure [dBP] 100 mmHg) versus tight control (target dBP 85

PLACENTAL WEIGHT AND ITS ASSOCIATION WITH MATERNAL AND NEONATAL CHARACTERISTICS

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M Asgharnia

2008-12-01

Full Text Available "nPlacenta plays a vital role in normal fetal development and failure of placenta to gain weight and insufficiency of its function can result in fetal disorders. We performed this study to determine placental weight and factors associated with low weight placentas. In a longitudinal cross-sectional study, women with single pregnancy, and gestational age between 37-42 weeks were studied. The subjects were categorized in high (> 750 g, normal (330-750 g, and low placental weights (< 330 g. The placental weight, birth weight, maternal age, gestational age, parity, pre-eclampsia, history of maternal diabetes, delivery approaches, infants' gender; and Apgar score in 5th minutes after delivery were examined. One thousand-eighty eight pregnant women were included in the study. The mean and standard deviation for maternal ages and gestational ages at deliveries were 25.35 ± 5.6 and 247.51 ± 9.56 days, respectively. The mean and standard deviation of neonates' weights at birth and placental weights were 3214.28 ± 529 and 529.72 ± 113 g, respectively. The prevalences of low and high placental weights were 2% and 2.8%, respectively. There were statistically significant relationships between placental weight and birth weight, fetal distress, Apgar score, maternal diabetes, pre-eclampsia and approaches of deliveries (α = 0.05. Our findings indicate that placental weight can be associated with important variables influencing some maternal and neonatal outcomes and placental weight lower than 330 g can be a warning sign. Careful attention to placenta growth during pregnancy, for example by ultrasonography, can guide physicians to assess neonatal health.

The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial.

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Ibrahim, Moustafa Ibrahim; Hamdy, Ahmed; Shafik, Adel; Taha, Salah; Anwar, Mohammed; Faris, Mohammed

2014-05-01

The aim of the present study is to assess the impact of adding oral metformin to insulin therapy in pregnant women with insulin-resistant diabetes mellitus. The current non-inferiority randomized controlled trial was conducted at Ain Shams University Maternity Hospital. The study included pregnant women with gestational or pre-existing diabetes mellitus at gestations between 20 and 34 weeks, who showed insulin resistance (defined as poor glycemic control at a daily dose of ≥1.12 units/kg). Recruited women were randomized into one of two groups: group I, including women who received oral metformin without increasing the insulin dose; and group II, including women who had their insulin dose increased. The primary outcome was maternal glycemic control. Secondary outcomes included maternal bouts of hypoglycemia, need for another hospital admission for uncontrolled diabetes during pregnancy, gestational age at delivery, mode of delivery, birth weight, birth trauma, congenital anomalies, 1- and 5-min Apgar score, neonatal hypoglycemia, need for neonatal intensive care unit (NICU) admission and adverse neonatal outcomes. A total number of 154 women with diabetes mellitus with pregnancy were approached; of them 90 women were eligible and were randomly allocated and included in the final analysis. The recruited 90 women were randomized into one of two groups: group I (metformin group) (n = 46), including women who received oral metformin in addition to the same initial insulin dose; and group II (control group) (n = 44), including women who had their insulin dose increased according to the standard protocol. The mean age of included women was 29.84 ± 5.37 years (range 20-42 years). The mean gestational age at recruitment was 28.7 ± 3.71 weeks (range 21-34 weeks). Among the 46 women of group I, 17 (36.9 %) women reached proper glycemic control at a daily metformin dose of 1,500 mg, 18 (39.2 %) at a daily dose of 2,000 mg, while 11 (23.9 %) received metformin at a daily

Determination of risk factors for pre-eclampsia and eclampsia in a tertiary hospital of India: A case control study

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Punyatoya Bej

2013-01-01

Full Text Available Background: Preeclampsia and eclampsia (PE are pregnancy specific syndromes that contribute to maternal and fetal morbidity and mortality. The identification of its predisposing factors in the pre-pregnancy and initial stage of pregnancy will help in reducing the morbidity and mortality. Aim: The aim of this study is to determine the risk factors for PE among pregnant women in a tertiary level hospital. Materials and Methods: In this study, 122 women who delivered beyond 22 weeks of gestation and diagnosed as preeclampsia or eclampsia were selected. Simultaneously, 122 controls with no diagnosis of preeclampsia or eclampsia were selected from the post natal ward. Cases and controls were administered the same pre-tested questionnaire containing different risk factors. Results and Conclusion: Logistic regression was applied in the statistical analysis. The factors that were found to be significant predictors of risk for development of PE were family history of preeclampsia (adjusted odds ratio [OR] 18.57 [1.93-178.16], P = 0.011, higher calorie intake (adjusted OR 14.12 [6.41-43.23] body mass index (adjusted P < 0.001, employment (adjusted OR 6.35 [1.56-25.82] P = 0.010], less protein intake (adjusted OR 3.87 [1.97-8.01] P < 0.001, increased OR 5.86 [02.48-13.8] P < 0.001, mild physical activities (adjusted OR 3.46 [1.06-11.24] P = 0.039. Past history of hypertension and diabetes mellitus were also associated with development of PE.

Defining an abnormal first stage of labor based on maternal and neonatal outcomes

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Harper, Lorie M.; Caughey, Aaron B.; Roehl, Kimberly A.; Odibo, Anthony O.; Cahill, Alison G.

2014-01-01

OBJECTIVE The objective of the study was to determine the threshold for defining abnormal labor that is associated with adverse maternal and neonatal outcomes. STUDY DESIGN This study consisted of a retrospective cohort of all consecutive women admitted at a gestation of 37.0 weeks or longer from 2004 to 2008 who reached the second stage of labor. The 90th, 95th, and 97th percentiles for progress in the first stage of labor were determined specific for parity and labor onset. Women with a first stage above and below each centile were compared. Maternal outcomes were cesarean delivery in the second stage, operative delivery, prolonged second stage, postpartum hemorrhage, and maternal fever. Neonatal outcomes were a composite of the following: admission to level 2 or 3 nursery, 5 minute Apgar less than 3, shoulder dystocia, arterial cord pH of less than 7.0, and a cord base excess of −12 or less. RESULTS Of the 5030 women, 4534 experienced first stage of less than the 90th percentile, 251 between the 90th and 94th percentiles, 102 between the 95th and 96th percentiles, and 143 at the 97th percentile or greater. Longer labors were associated with an increased risk of a prolonged second stage, maternal fever, the composite neonatal outcome, shoulder dystocia, and admission to a level 2 or 3 nursery (P dystocia. CONCLUSION Although women who experience labor dystocia may ultimately deliver vaginally, a longer first stage of labor is associated with adverse maternal and neonatal outcomes, in particular shoulder dystocia. This risk must be balanced against the risks of cesarean delivery for labor arrest. PMID:24361789