Balloon + Oxytocin versus Oral Misoprostol to Induce labor in case of premature rupture of membranes (PROM) at term in nulliparous
- Conditions
- pregnant women with premature rupture of membranesTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2022-501142-30-00
- Lead Sponsor
- CHU Gabriel-Montpied
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 520
Age > 18 years old, Pregnant, Gestational age = 37 weeks, Singleton pregnancy with cephalic presentation, Nulliparous, PROM occurring = 37 weeks + 0 day and 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
Unable to understand French language, Known HIV seropositivity, Placenta praevia, Fetal death, Abnormal FHR (Fetal Heart Rate), Contraindication to misoprostol, Contraindication to balloon, Contraindication to oxytocin, Patient subject to a legal protection order (curatorship or tutorship), Refusal to participate, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method