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Balloon + Oxytocin versus Oral Misoprostol to Induce labor in case of premature rupture of membranes (PROM) at term in nulliparous
EU CTIS ID: 2022-501142-30-00
What this study is testing
to demonstrate higher rate of vaginal birth <24h by insertion of a balloon catheter + oxytocin after 6h, versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of unfavorable cervix beyond 12 hours of PROM in nulliparous and to compare patient satisfaction using EXIT survey translated in French language before hospital discharge
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Unable to understand French language
- Known HIV seropositivity
- Placenta praevia
- Fetal death
- Abnormal FHR (Fetal Heart Rate)
- Contraindication to misoprostol
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.