Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)

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.

Comparison of the efficacy between controlled‐release dinoprostone delivery system (PROPESS) and Cook's double balloon catheter plus oxytocin: A retrospective single‐center study in Japan

“…Yan et al 12 and Du et al 3 reported that dinoprostone vaginal insert are more effective for labor induction than Cook's DBC, which could support our findings to some extent. In contrast, a randomized controlled trial on cases with rupture of membranes did not find any differences between dinoprostone and DBC plus oxytocin 13 . We speculate that population variation may be one of the main reasons for the discrepancy from our findings, because the present study focused mainly on Japanese pregnant women with intact membranes.…”

“…In contrast, a randomized controlled trial on cases with rupture of membranes did not find any differences between dinoprostone and DBC plus oxytocin. 13 We speculate that population variation may be one of the main reasons for the discrepancy from our findings, because the present study focused mainly on Japanese pregnant women with intact membranes.…”

“…Theoretically, comparing the DBC plus oxytocin, PROPESS has the advantage of less pain associated with insertion and a lower risk of intrauterine infection. 17,18 Although the limited data from our study and a previous report 13 showed no statistical differences concerning the adverse outcomes, PROPESS is prone to cause uterine hyperstimulation, which can induce nonreassuring fetal heart rate pattern. 19 Therefore, the optimal choice of induction treatment should be managed on an individual basis.…”

Experience of dinoprostone vaginal insert using for cervical ripening and induction of labor

“…Анализ полученных результатов исследования показал, что наиболее часто подготовка шейки матки и родовозбуждение встречаются у первородящих женщин и наиболее частыми показаниями являются преждевременный разрыв плодных оболочек и тенденция к перенашиванию беременности, что совпадает с данными литературы [11][12][13][14].…”

A model to predict delivery time by induction of labour at term with a dinoprostone vaginal insert：A retrospective study

“…The median DT was 8 hours faster for women who underwent early arti cial rupture than in women with expectant management [18]. Nevertheless, Eric Devillard et al compared a double balloon catheter with oxytocin versus a vaginal dinoprostone insert in women with PROM at term and found that there was no signi cant difference in DT between the two groups [19]. It would be interesting to explore the mechanism for the decreased DT, and we concluded that the decreased DT due to PROM was rarely related to the method of IOL.…”