Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
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.