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Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)
Sponsor: University Hospital, Clermont-Ferrand
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.
Official title: Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of Premature Rupture of Membranes (PROM) at Term in Nulliparous: a Randomized Controlled Trial (RUBAPRO2).
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2023-01-18
Completion Date
2025-08-29
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Balloon for cervical ripening (Teleflex French Dufour catheter CH20 reference 174000)
Balloon catheter is inserted by a resident or a physician under visual control. The expected volume injected in the balloon probe is 60 mL. No traction is performed on the catheter. The catheter is left in place for a maximum of 12 hours.
Oxytocin
Intravenous oxytocin addition (preceded or followed by epidural analgesia on patient's request) will be performed 6 hours after insertion of balloon catheter. Oxytocin is administered as an intravenous infusion (5 IU of oxytocin in 49 mL of 5% glucose\*) at the lowest possible dose with the aim of achieving a maximum of three to four contractions per ten minutes. After appropriate uterine activity has been achieved, the rate of the oxytocin infusion is decreased or stopped.
Misoprostol Oral Tablet
Patients will receive misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.
Locations (5)
CHU de Bordeaux
Bordeaux, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Assistance Publique Hôpitaux de Paris- CHU Bicêtre
Le Kremlin-Bicêtre, France
CHU de Saint Etienne
Saint-Etienne, France
CHU de Toulouse
Toulouse, France