Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)

Summary

Premature rupture of membranes (PROM) at term complicates 6 to 22% of singleton pregnancies. Spontaneous labour occurs in 60-67% of these patients within 24h. If no effective uterine contraction occurs, induction of labour (IOL) is the strategy recommended by the French as well as the American College of Obstetricians and Gynecologists. The optimal strategy for IOL in case of PROM with an unfavourable cervix remains unknown and none of the studies conducted in nulliparous women showed the superiority of one induction method over another. In the current project, we aimed to determine (1) if IOL with association of balloon catheter and oxytocin after 6 hours could increase the rate of delivery \< 24h versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of PROM at term in nulliparous women and (2) patient satisfaction using EXIT survey assessed before hospital discharge.

Timeline

Start

2023-01-18

Primary completion

2025-02

Completion

2026-02

Publications

• Rouzaire M, Triolaire A, Vayssiere C, Sentilhes L, Barjat T, Luton D; Groupe de Recherche en Obstetrique et Gynecologie (GROG) Investigators; Davoust E, Cabrespine A, Pereira B, Gallot D. Balloon plus oxytocin or oral misoprostol for labour induction in prelabour rupture of membranes (PROM): protocol for a randomised controlled trial (RUBAPRO2). BMJ Open. 2026 Jan 27;16(1):e110425. doi: 10.1136/bmjopen-2025-110425.

Drugs

Indications