Inducing labor with balloon and oxytocin versus oral misoprostol for women with premature rupture of membranes
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).
This study tests if using a balloon and oxytocin to induce labor is better than taking oral misoprostol for first-time moms whose water has broken early, to see if it helps them deliver faster and feel more satisfied.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT05568745 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of using a combination of a balloon catheter and oxytocin compared to oral misoprostol for inducing labor in nulliparous women with premature rupture of membranes (PROM) at term. The study aims to determine if this combination can increase the rate of delivery within 24 hours and improve patient satisfaction. Participants will be monitored for their delivery outcomes and satisfaction through an EXIT survey before discharge. The trial is conducted in multiple locations in France, focusing on women who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women over 18 years old, at least 37 weeks pregnant, with PROM and an unfavorable cervix.
Not a fit: Patients who may not benefit from this study include those with contraindications for vaginal delivery or existing infections.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and timely labor induction for women experiencing PROM, potentially reducing the need for cesarean sections.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential effectiveness in labor induction methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 4 other locations
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- Assistance Publique Hôpitaux de Paris- CHU Bicêtre — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- CHU de Saint Etienne — Saint-Étienne, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Denis Gallot — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.