Abstract
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.
Highlights
The premature rupture of membranes (PROM) at term, a complication in 8% of pregnancies [1], is associated with risk of chorioamnionitis and neonatal sepsis, which increase with PROM duration [2,3]
Since the optimal method for induction of labor (IOL) in cases of PROM at term is currently unknown, the main objective of this study was to determine whether the use of a double balloon catheter combined with oxytocin would lead to a reduction in time between IOL and delivery (TID) when compared to a vaginal dinoprostone insert
The RUBAPRO trial failed to demonstrate that the association of a double balloon catheter with oxytocin decreased TID, compared to a vaginal dinoprostone insert except in nulliparous women, for whom a difference of 9 h was observed
Summary
The premature rupture of membranes (PROM) at term, a complication in 8% of pregnancies [1], is associated with risk of chorioamnionitis and neonatal sepsis, which increase with PROM duration [2,3]. Studies comparing a mechanical device (Foley catheter) for IOL in cases of PROM versus prostaglandins or oxytocin have reported similar time intervals from induction to delivery, and no differences concerning maternal or neonatal infections have been reported, with the exception of one retrospective study that revealed quicker deliveries associated with a Foley catheter [8–11]. Two trials conducted in women with PROM at 34 or more gestational weeks reported that the combined use of a Foley catheter and oxytocin was not found to shorten the time to delivery, compared with oxytocin alone [9,10] In one of these trials, an increased risk of intra-amniotic infection was found. 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.
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