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: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Misoprostol; Oxytocin

Criteria

Inclusion Criteria:

• Age > 18 years old,

• Pregnant, Gestational age ≥ 37 weeks

• Singleton pregnancy with cephalic presentation

• Nulliparous

• PROM without labour beyond 12 hours

• Unfavourable cervix (Bischop score < 6)

• Able to give her informed consent

• Ability to comply with the requirement of the study

• Covered by the French Social Security welfare system

Exclusion Criteria:

• Unable to understand French language

• Contraindication for vaginal delivery

• Loss of meconium amniotic fluid (LA)

• Temperature > 38.2°C

• Intrauterine infection

• IUGR with Doppler anomaly

• Fetus with expected polymalformative syndrome

• Scarred womb

• Suspicion of genital herpes

• Known HIV seropositivity

• Placenta praevia

• Fetal death

• Abnormal FHR (Fetal Heart Rate)

• Contraindication to misoprostol:

• Allergy or hypersensibility

• Suspicion or confirmation of a scarred uterus following past surgical intervention

• Renal insufficiency

• Malformation of the uterus

• Contraindication to balloon:

• Vasa praevia, placenta praevia

• Invasive cervical cancer

• Contraindication to oxytocin

• Allergy or hypersensibility

• Dystocia

• Fragility or excessive distension of the uterus

• Uterine hypertonia or fetal distress when delivery is not imminent

• Cardiovascular disorders and severe preeclampsia

• Predisposition to amniotic embolism (in utero fetal demise, abruption).

• Patient subject to a legal protection order (curatorship or tutorship)

• Refusal to participate