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.
Objective: To demonstrate that a double balloon catheter combined with
oxytocin decreases time between induction of labour and delivery (TID)
as compared to a vaginal dinoprostone insert in cases of PROM at term.
Design: Prospective, randomized, controlled trial. Setting: French
university hospital Population: Patients undergoing labour induction for
PROM at term with unfavorable cervix. Methods: We compared the double
balloon catheter over a period of 12 hours with adjunction of oxytocin 6
hours after catheter insertion, versus dinoprostone vaginal insert.
After device ablation, cervical ripening continued only with oxytocin.
Main outcome measures: The primary outcome was TID. Secondary outcomes
concerned delivery mode, 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 vs 20.2 hours, ES = 0.16 (-0.27 to 0.60), p=0.12) in
catheter group versus dinoprostone except in nulliparous women (17.0 vs
26.5 hours, ES = 0.62 (0.10 to 1.14), p=0.006). The rate of vaginal
delivery <24h significantly increased with combined induction
(88.5% vs 66.6%, p=0.03). No statistical difference was observed
concerning caesarean rate (12.5% vs 17.5%, p>0.05),
chorioamnionitis (0% vs 2.5%, p=1), postpartum endometritis, maternal
or neonatal outcomes. Procedure-related pain and tolerance to devices
were found to be similar for the two methods. Conclusion: 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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