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. 2022 Mar 10;11(6):1525.
doi: 10.3390/jcm11061525.

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

Eric Devillard  1   2 , Fanny Petillon  1 , Marion Rouzaire  1 , Bruno Pereira  3 , Marie Accoceberry  1 , Céline Houlle  1 , Lydie Dejou-Bouillet  1 , Pamela Bouchet  1 , Amélie Delabaere  1   4 , Denis Gallot  1   4
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Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO)

Eric Devillard et al. J Clin Med. .

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.

Keywords: cervical ripening balloon; labor induction; nulliparous; premature rupture of membranes; unfavorable cervix.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flowchart describing the main stages of the study.
Figure 2
Figure 2
Flowchart of randomization into treatment groups.
Figure 3
Figure 3
Kaplan–Meier survival curves illustrating induction to delivery time: (a) for entire study population; (b) for nulliparous and all deliveries modes; (c) for nulliparous and vaginal delivery; (d) for multiparous and all deliveries modes; (e) for multiparous and vaginal delivery.
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