The aim is to compare the prevalence of maternal deficiencies in micronutrients, the obstetrical and neonatal complications after bariatric surgery according to surgical techniques, the time between surgery and conception, and BMI at the onset of pregnancy. A retrospective cohort study concerned 57 singleton pregnancies between 2011 and 2016 of 48 adult women who have undergone bariatric surgery. Small-for-gestational-age neonates were identified in 36.0% of pregnancies. With supplements intake (periconceptional period: 56.8%, trimester 1 (T1): 77.8%, T2: 96.3%, and T3: 100.0%), nutritional deficiencies involved vitamins A (T1: 36.4%, T2: 21.1%, and T3: 40.0%), D (T1: 33.3%, T2: 26.3%, and T3: 8.3%), C (T1: 66.7%, T2: 41.2%, and T3: 83.3%), B1 (T1: 45.5%, T2: 15.4%, and T3: 20.0%), and B9 (T1: 14.3%, T2: 0%, and T3: 9.1%) and selenium (T1: 77.8%, T2: 22.2%, and T3: 50.0%). There was no significant difference in the prevalence of nutritional deficiencies and complications according to surgery procedures and in the prevalence of pregnancy issues according to BMI at the beginning of the pregnancy and time between surgery and pregnancy. Prevalence of micronutritional deficiencies and small-for-gestational-age neonates is high in pregnant women following bariatric surgery. Specific nutritional programmes should be recommended for these women.
IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12–24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups—with a statistical power of 90% and a two-tailed α of 5%—40 patients per group will be required.Ethics and disseminationWritten informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial registration numberNCT03310333.
Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.
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