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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, [greater than or equal to]41+0 and [less than or equal to]42+0 weeks' gestation, a Bishop score 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., Author(s): Caroline Diguisto 1,2,3,*, Amélie Le Gouge 4, Chloé Arthuis 5, Norbert Winer 5, Olivier Parant 6, Christophe Poncelet 7,8, Celine Chauleur 9,10, Jacob Hannigsberg 11, Guillaume Ducarme 12, Denis [...]

Introduction: This trial evaluates whether daily low-dose aspirin initiated before 16 weeks of gestation can reduce preeclampsia and fetal growth restriction in nulliparous women identified by first-trimester uterine artery Dopplers as at high risk of preeclampsia. Methods: This randomized, blinded, placebo-controlled, parallel-group trial took place in 17 French obstetric departments providing antenatal care. Pregnant nulliparous women aged ≥ 18 years with a singleton pregnancy at a gestational age < 16 weeks of gestation with a lowest pulsatility index ≥ 1.7 or a bilateral protodiastolic notching for both uterine arteries on an ultrasound performed between 11+0 and 13+6 weeks by a certified sonographer were randomized at a 1:1 ratio to 160 mg of low-dose aspirin or to placebo to be taken daily from inclusion to their 34th week of gestation. The main outcome was preeclampsia or a birthweight ≤ 5th percentile. Other outcomes included preeclampsia, severe preeclampsia, preterm preeclampsia, preterm delivery before 34 weeks, mode of delivery, type of anesthesia, birthweight ≤ 5th percentile and perinatal death. Results: The trial was interrupted due to recruiting difficulties. Between June 2012 and June 2016, 1104 women were randomized, two withdrew consent, and two had terminations of pregnancies. Preeclampsia or a birthweight ≤ 5th percentile occurred in 88 (16.0%) women in the low-dose aspirin group and in 79 (14.4%) in the placebo group (proportion difference 1.6 [-2.6; 5.9] p = 0.45). The two groups did not differ significantly for the secondary outcomes. Conclusion: Low-dose aspirin was not associated with a lower rate of either preeclampsia or birthweight ≤ 5th percentile in women identified by their first-trimester uterine artery Doppler as at high risk of preeclampsia. Trial registration: (NCT0172946). [ABSTRACT FROM AUTHOR]

Introduction: Previous studies of fetal effects have suggested that intrahepatic cholestasis of pregnancy is associated with a higher rate of adverse neonatal outcomes including preterm birth, neonatal respiratory distress syndrome, meconium-stained amniotic fluid, neonatal intensive care unit admission, and stillbirth. The objective was to compare the neonatal and maternal consequences in pregnancies affected by intrahepatic cholestasis and normal pregnancies. Material and methods: This case-control study compares pregnancies affected by intrahepatic cholestasis (pruritus and bile acid ≥ 10 μmol/L) with low-risk pregnancies managed between December 2006 and December 2014 at a French university hospital center. Results: There were 83 (59.3%) cases of mild cholestasis (10≤ BA ≤39 μmol/L), 46 (32.8%) of moderate cholestasis (40≤ BA ≤99 μmol/L), and 11 (7.9%) of severe cholestasis (BA ≥100 μmol/L). No in utero fetal deaths occurred in the 140 women with cholestasis or the 560 controls analyzed. The rate of respiratory distress syndrome was higher in neonates of women with intrahepatic cholestasis (17.1% vs. 4.6%, P<0.001; crude OR 4.46 (CI95% 2.49–8.03)). This risk was also significant after adjustment for gestational age at birth and mode of delivery, adjusted OR 2.56 (CI95%1.26–5.18). The postpartum hemorrhage rate was twice as high among the case mothers (25% versus 14.1% for controls, P = 0.002). Conclusion: After adjustment on the confounding factors we found a higher rate of respiratory distress syndrome and neonatal morbidity among neonates of the cholestasis group. [ABSTRACT FROM AUTHOR]

Objective: Our main objective was to examine if parental prenatal preferences predict delivery-room management of extremely preterm periviable infants. The secondary objectives were to describe parental involvement and the content of prenatal counseling given to parents for this prenatal decision. Design: Prospective study of neonates liveborn between 22 and 26 weeks of gestation in France in 2011 among the neonates included in the EPIPAGE-2 study Setting: 18 centers participating in the “Extreme Prematurity Group” substudy of the EPIPAGE-2 study. Patients: 302 neonates liveborn between 22–26 weeks among which 113 with known parental preferences while parental preferences were unknown or unavailable for 186 and delivery room management was missing for 3. Results: Data on prenatal counseling and parental preferences were collected by a questionnaire completed by professionals who cared for the baby at birth; delivery room (DR) management, classified as stabilization or initiation of resuscitation (SIR) vs comfort care (CC). The 113 neonates studied had a mean (SD) gestational age of 24 (0.1) weeks. Parents of neonates in the CC group preferred SIR less frequently than those with neonates in the SIR group (16% vs 88%, p < .001). After multivariate analysis, preference for SIR was an independent factor associated with this management. Professionals qualified decisions as shared (81%), exclusively medical (16%) or parental (3%). Information was described as medical with no personal opinion (71%), complete (75%) and generally pessimistic (54%). Conclusion: Parental involvement in prenatal decision-making did not reach satisfying rates in the studied setting. When available, prenatal parental preference was a determining factor for DR management of extremely preterm neonates. Potential biases in the content of prenatal counselling given to parents need to be evaluated. [ABSTRACT FROM AUTHOR]

Background: Clinical guidelines do not recommend maintenance tocolysis for the management of preterm labour. The French national survey EVAPRIMA revealed it was administered to more than 50% of women hospitalised for preterm labour. Our aim was to identify the individual and organisational determinants associated with maintenance tocolysis. Methods: The study was a secondary analysis of the prospective population-based EVAPRIMA study database. Population study included every women hospitalised for preterm labour and at risk of receiving maintenance tocolysis, over a one month period, in 99 randomly selected French maternity units. Main outcome was the prescription of maintenance tocolysis. The association between maintenance tocolysis and individual (maternal or obstetrical) and organisational determinants were evaluated with multilevel analysis. Results: Of the 531 women included, 68.9% (95% CI 0.65-0.73) received maintenance tocolysis. The only individual factor associated with maintenance tocolysis was gestational age at admission; the rate of maintenance tocolysis was higher among women hospitalised before 32 weeks of gestation. The significantly different rates between maternity units demonstrated the existence of a maternity unit effect. Maintenance tocolysis was also associated with organisational determinants and was more frequent in level 1 (ORa = 6.54[2.21-19.40]) and level 2 maternity units (ORa = 3.68[1.28-10.59]), in units with less than 1500 deliveries/year (ORa = 5.27[4.43-19.44]), and in specific areas of France. Conclusion: A maternity unit effect, explained partly by the organisational characteristics of the units, plays a major role in the practice of maintenance tocolysis. Widespread dissemination of these results might improve adherence to clinical guidelines. [ABSTRACT FROM AUTHOR]