Double balloon catheter (+oxytocin) versus dinoprostone vaginal insert
for term rupture of membranes: a randomized controlled trial (RUBAPRO)
Abstract
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.