Search

Background: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2).Methods and Findings: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section.Conclusions: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone.Trial Registration: ClinicalTrials.gov NCT02907060. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether staffing levels of maternity units affect prelabor urgent, elective, and intrapartum cesarean delivery rates. Methods: This population-based retrospective cohort study covers the deliveries of the 11 hospitals of a French perinatal network in 2008–2014 (N = 102 236). The independent variables were women’s demographic and medical characteristics as well as the type, organization, and staffing levels for obstetricians, anesthesiologists, and midwives of each maternity unit. Bivariate and multivariate analyses were conducted with multilevel logistic models. Results: Overall, 23.9% of the women had cesarean deliveries (2.4% urgent before labor, 10% elective, and 11.5% intrapartum). Independently of individual- and hospital-level factors, the level of obstetricians, measured by the number of full-time equivalent persons (i.e., 35 working hours per week) per 100 deliveries, was negatively associated with intrapartum cesarean delivery (adjusted odds ratio, aOR 0.55, 95% confidence interval, CI 0.36–0.83, P-value = 0.005), and the level of midwives negatively associated with elective cesarean delivery (aOR 0.79, 95% CI 0.69–0.90, P-value < 0.001). Accordingly, a 10% increase in obstetrician and midwife staff levels, respectively, would have been associated with a decrease in the likelihood of intrapartum cesarean delivery by 2.5 percentage points and that of elective cesarean delivery by 3.4 percentage points. These changes represent decreases in intrapartum and elective cesarean delivery rates of 19% (from 13.1% to 10.6%) and 33% (from 10.3% to 6.9%), respectively. Conclusion: Staffing levels of maternity units affect the use of cesarean deliveries. High staffing levels for obstetricians and midwives are associated with lower cesarean rates. [ABSTRACT FROM AUTHOR]

Objective: The objective of the study is to assess the utility of an intermediate ultrasound scan at 16(+0) to 18(+6)  weeks of gestation in euploid fetuses with increased nuchal translucency ≥ 3.5 mm.Methods: Three hundred eighty-nine fetuses with nuchal translucency (NT) ≥ 3.5 mm were identified in two prenatal centers between January 2008 and December 2012. Pregnancy work-up included karyotyping, monthly detailed ultrasound scan starting with a 16th-week scan, a cardioechography, and a genetic counseling. Abnormal findings and pregnancy outcomes were analyzed retrospectively.Results: Of the 389 fetuses included, 52% had normal karyotype. Among euploid fetuses, 51 (30.7%) structural defects were identified overall. First-trimester scan was useful to identify 16 of the major defects (31.3%), and the 16th-week scan was useful to identify an additional 21 of them (41.2%), whereas the 22nd-week pregnancy scan discovered an additional 14 (27.4%). Structural defects discovered with the 16th-week scan were cardiac defects (n = 7), polymalformative syndromes (n = 3), left diaphragmatic hernias (n = 3), limbs abnormalities (n = 2), genitourinary (n = 2), microretrognathism (n = 2), hydrops (n = 1), and exomphalos (n = 1). If the intermediate scan was normal, the chances of a favorable outcome were as high as 85% and were close to 100% after 20 weeks, irrespective of initial NT.Conclusion: The intermediate ultrasound was useful in fetuses with increased NT pregnancy work-up. [ABSTRACT FROM AUTHOR]

Background Severe pre-eclampsia ( SPE) is the second cause of maternal death in developed countries. The literature suggests different risk factors for early- and late-onset pre-eclampsia. SPE is usually related to the early-onset type. Pre-eclampsia rate exhibits seasonal variation. However, the weather- SPE association is still unknown. We examined the associations between maternal exposure to meteorological parameters after conception and SPE. Methods From 2008 to 2011, all deliveries of women living in the Yvelines area, France, have been prospectively registered. Meteorological measurements from weather stations scattered inside Yvelines were averaged on two exposure windows: early-pregnancy (30 days after conception) and first-trimester (90 days after conception). The relationship between SPE and season of conception was also examined. Hierarchical complementary log-log regression models were used to estimate the weather- SPE association. Results SPE was diagnosed in 526 (0.8%) out of 63 633 singleton pregnancies. Increasing temperature or sunshine across both windows was associated with increased SPE risk. Early-pregnancy minimum temperature showed the strongest effect with adjusted odds ratio ( OR) per 1 degree Celsius: 1.03 [95% confidence interval ( CI) 1.01, 1.04]. The risk of SPE was higher when conception was in summer as compared to winter ( OR 1.53, 95% CI 1.27, 1.85). Effect estimates showed only small variations in sensitivity analyses. Conclusions Our findings of a weather impact during early pregnancy on SPE may provide a new clue for understanding the causes of pre-eclampsia. Further investigation into the biologic mechanisms for this finding is required. [ABSTRACT FROM AUTHOR]

Objective: The magnitude and direction of effects on pregnancy outcomes of the lockdown imposed during COVID-19 have been uncertain and debated. Therefore, we aimed to quantify delivery and perinatal outcomes during the first nationwide lockdown due to the COVID-19 pandemic compared with the same durations of time for the pre- and post-lockdown periods. Study design: This was a retrospective cohort study of six university hospital maternity units distributed across France, each of which serves as the obstetric care referral unit within its respective perinatal network. Maternal and perinatal outcomes were compared between the lockdown period and same-duration (i.e., 55-day) periods before and after the 2020 lockdown (pre-lockdown: 22 January–16 March; lockdown: 17 March–10 May; post-lockdown: 11 May–4 July). We compared the overall rates of Caesarean delivery (CD), pre-labor CD, labor induction, operative vaginal delivery, severe postpartum hemorrhage (≥1 L), severe perineal tear, maternal transfusion, and neonatal mortality and morbidity (1- and 5-min Apgar scores < 7), hypoxia and anoxia (umbilical arterial pH < 7.20 or <7.10, respectively), and admission to a neonatal intensive care unit before discharge. Adjusted odds ratios were estimated using logistic regression, controlling for region of birth, maternal age category, multiparity, multiple pregnancies, diabetes, and hypertensive disorders. Results: The study sample consisted of 11,929 women who delivered consecutively at one of the six maternity units studied (4093 pre-lockdown, 3829 during lockdown, and 4007 post-lockdown) and their 12,179 neonates (4169 pre-lockdown, 3905 during lockdown, and 4105 post-lockdown). The maternal and obstetric characteristics of the women delivering during the lockdown period were alike those delivering pre- and post-lockdown on maternal age, parity, body mass index, rate of complication by hypertensive disorders or insulin-treated diabetes, and gestational age at delivery. Overall CD rates were similar during the three periods (23.6%, 24.8%, and 24.3% pre-lockdown, lockdown, and post-lockdown, respectively) and no outcome differed significantly during lockdown compared to pre- and post-lockdown. These findings were consistent across maternity units. Conclusion: The maternal and perinatal outcomes are reassuring regarding the performance of the health-care system during the COVID-19 lockdown studied. Such information is crucial, because additional COVID-19-related lockdowns might still be needed. They are also instructive regarding potential future pandemics. [ABSTRACT FROM AUTHOR]

Objective: In the context of rapid changes regarding practices related to delivery in Africa, we assessed maternal and perinatal adverse outcomes associated with the mode of delivery in 41 referral hospitals of Mali and Senegal. Study Design: Cross-sectional survey nested in a randomised cluster trial (1/10/2007-1/10/2008). The associations between intended mode of delivery and (i) in-hospital maternal mortality, (ii) maternal morbidity (transfusion or hysterectomy), (iii) stillbirth or neonatal death before Day 1 and (iv) neonatal death between 24 hours after birth and hospital discharge were examined. We excluded women with immediate life threatening maternal or fetal complication to avoid indication bias. The analyses were performed using hierarchical logistic mixed models with random intercept and were adjusted for women's, newborn's and hospitals' characteristics. Results: Among the 78,166 included women, 2.2% had a pre-labor cesarean section (CS) and 97.8% had a trial of labor. Among women with a trial of labor, 87.5% delivered vaginally and 12.5% had intrapartum CS. Pre-labor CS was associated with a marked reduction in the risk of stillbirth or neonatal death before Day 1 as compared with trial of labor (OR = 0.2 [0.16-0.36]), though we did not show that maternal mortality (OR = 0.3 [0.07-1.32]) and neonatal mortality after Day 1 (OR= 1.3 (0.66-2.72]) differed significantly between groups. Among women with trial of labor, intrapartum CS and operative vaginal delivery were associated with higher risks of maternal mortality and morbidity, and neonatal mortality after Day , as compared with spontaneous vaginal delivery. Conclusions: In referral hospitals of Mali and Senegal, pre-labor CS is a safe procedure although intrapartum CS and operative vaginal delivery are associated with increased risks in mothers and infants. Further research is needed to determine what aspects of obstetric care contribute to a delay in the provision of intrapartum interventions so that practices may be made safer when they are needed. [ABSTRACT FROM AUTHOR]

Objective: The effect of lockdowns during the coronavirus (COVID-19) pandemic on pregnancy outcomes remains uncertain. We aimed to evaluate the association between the COVID-19-related lockdown and pregnancy outcomes in maternity hospitals in France. Study design: This was a retrospective cohort study from six tertiary referral hospitals in different regions of France. Three 55-day periods were compared: pre-lockdown from 22 January 2020, lockdown from 17 March 2020, and post-lockdown from 11 May 2020 to 4 July 2020. We included all women who delivered singleton or multiple pregnancies, who delivered at ≥24 weeks of gestation and with birthweights ≥500 g. We documented gestational ages at the delivery of liveborn and stillborn infants ('stillbirths'). These were categorized as having a very low birthweight (VLBW, <1500 g), or a low birthweight (LBW, <2500 g). Adjustments were made for place of birth, maternal age, parity and diabetes, and hypertensive disorders, as well as for multiple pregnancies. Results: In total, 11,929 women delivered in the six selected centers. This figure is constituted of 4093, 3829, and 4007 deliveries in the pre-lockdown (1), peri-lockdown (2), and post-lockdown (3) periods, respectively. There were no differences in pregnancy outcomes between these three periods. Overall, birth rates <27+6 weeks, between weeks 28+0 and 31+6, and between 32+0 and weeks 36+6 were 1.0%, 1.9%, and 4.4%, respectively. After adjustment, these rates were stable between periods 1 and 2 (adjusted odds ratio, aOR 0.90; 95% confidence interval, CI 0.69–1.19) and between periods 2 and 3 (aOR 1.04; 95% CI 0.80–1.36). Although more VLBW neonates were born during lockdown (3.5% vs. 2.6%, p = 0.03), this difference did not persist after adjustment (aOR 0.84, CI 95% 0.64–1.10). The LBW rates were similar during the three periods at 12.5% overall. The stillbirth rate was unaffected by the lockdown. Conclusion: The pregnancy outcomes (preterm birth, LBW, VLBW, and stillbirth rates) were not modified by the COVID-19 lockdown in our cohort study in France. Considering the discrepancies in results and methodological issues in previous published studies, there is not sufficient evidence to conclude that such lockdowns have any impact on perinatal outcomes. [ABSTRACT FROM AUTHOR]

Objective: Recent studies have reported the efficacy of first-trimester combined screening for Down syndrome based on maternal age, serum markers (human chorionic gonadotropin, pregnancy-associated plasma protein A), and ultrasound measurement of fetal nuchal translucency. However, those do not incorporate the value of the widely accepted routine 20–22 weeks' anomaly scan. Study design: We carried out a multicenter, interventional study in the unselected population of a single health authority in order to assess the performance of first-trimester combined screening, followed by routine second trimester ultrasound examination and/or screening by maternal serum markers (free β-hCG and alpha-fetoprotein measurement or total hCG, alpha-fetoprotein, and unconjugated estriol measurement) when incidentally performed. Detection and screen positive rates were estimated using a correction method for nonverified issues. A cost analysis was also performed. Results: During the study period, 14,934 women were included. Fifty-one cases of Down syndrome were observed, giving a prevalence of 3.4 per 1000 pregnancies. Of these, 46 were diagnosed through first (n = 41) or second (n = 5) trimester screening. Among the 5 screen-negative Down syndrome cases, all were diagnosed postnatally after an uneventful pregnancy. Detection and screen positive rates of first-trimester combined screening were 79.6% and 2.7%, respectively. These features reached 89.7%, and 4.2%, respectively, when combined with second-trimester ultrasound screening. The average cost of the full screening procedure was 108 € ($120) per woman and the cost per diagnosed Down syndrome pregnancy was 7,118 € ($7909). Conclusion: Our findings suggest that 1 pragmatic interventional 2-step approach using first-trimester combined screening followed by second-trimester detailed ultrasound examination is a suitable and acceptable option for Down syndrome screening in pregnancy. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to compare the safety and efficacy of misoprostol and dinoprostone in pregnancies at high risk of fetal distress. Study design: Medical indications for the induction of labor with postdate pregnancy or intra-uterine growth restriction were randomized. A sequential design that was based on the triangular test was used. Results: At the fourth interim analysis, which included 140 patients, the trial was stopped because no significant difference was found in neonatal safety between misoprostol and dinoprostone, which was assessed on arterial cord pH < 7.20 (14.3% vs 10.0%, respectively; P = .60). Neonatal tolerance was similar in the 2 groups, with no difference in the cesarean delivery rate for fetal distress or in the incidence of meconium-stained amniotic fluid. Time to vaginal delivery was shortened by misoprostol (P = .03). Conclusion: Misoprostol and dinoprostone are equally safe for the induction of labor in pregnancies that are at high risk of fetal distress; however, misoprostol allowed the earlier induction of labor than did dinoprostone. [ABSTRACT FROM AUTHOR]

Objective: To investigate the association between twin pregnancy and severe acute maternal morbidity, overall and by timing (before, during or after delivery) and underlying causal condition.Methods: We conducted a cohort-nested case-control analysis from the EPIMOMS prospective study conducted in six French regions from 2012-2013 (N=182,309 deliveries). The case group comprised 2,500 women with severe acute maternal morbidity (defined by a national expert consensus process) occurring from 22 weeks of gestation and up to 42 days postpartum. A random sample of 3,650 women who gave birth without severe acute maternal morbidity made up the control group. The association between twin pregnancy and severe acute maternal morbidity was analyzed with multilevel multivariable logistic regression. The role of cesarean delivery as an intermediate factor between twin pregnancy and severe acute maternal morbidity was assessed by path analysis.Results: The population-based incidence of severe acute maternal morbidity was 6.2% (n=197/3,202, 95% CI 5.3-7.1) in twin pregnancies, and 1.3% (n=2,303/179,107, 95% CI 1.2-1.3) in singleton pregnancies. After controlling for confounders, the risk of severe acute maternal morbidity was higher in twin than in singleton pregnancies (adjusted odds ratio [OR] 4.2, 95% CI 3.1-5.8), both antepartum and intrapartum or postpartum, and regardless of the category of causal condition (severe hemorrhage, severe hypertensive complications, or other conditions). The association was also found for the most severe near-miss cases (adjusted OR 5.1, 95% CI 3.5-7.3). In path analysis, cesarean delivery mediated 20.6% (95% CI 12.9-28.2) of the total risk of intrapartum or postpartum severe acute maternal morbidity associated with twin pregnancy.Conclusion: Compared with women with singleton pregnancies, women with twin pregnancies have a fourfold increased risk for severe maternal complications both before and after delivery. About one fifth of the association between twin pregnancy and intrapartum or postpartum severe acute maternal morbidity may be mediated by cesarean delivery. [ABSTRACT FROM AUTHOR]