Balloon plus oxytocin or oral misoprostol for labour induction in prelabour rupture of membranes (PROM): protocol for a randomised controlled trial (RUBAPRO2).

ABSTRACT:

Introduction

The optimal strategy for induction of labour (IOL) in cases of prelabour rupture of membranes (PROM) with an unfavourable cervix is elusive. No study conducted in nulliparous women has shown any one induction method to be superior to any other. In this project, we seek to determine whether IOL with balloon catheter and oxytocin can (1) increase rate of delivery <24 hours and (2) increase patient satisfaction, compared with a low dose of oral misoprostol.

Methods and analysis

We are conducting a multicentre, randomised, controlled, open-label therapeutic trial with two parallel arms on nulliparous women with unfavourable cervix showing PROM at term without spontaneous labour.After 12 hours of PROM, women are randomly assigned to one of two study groups. One group

SUBMITTER: Rouzaire M 

PROVIDER: S-EPMC12853442 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature