3-hour Versus 12-hour Double-balloon Catheter for Labor Induction

Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial

This study aims to demonstrate that a 3-hour ultra-short cervical ripening protocol using a double-balloon catheter significantly reduces the induction-to-birth interval by at least 6 hours compared to the standard 12-hour protocol. The study evaluates whether this reduction can be achieved without increasing cesarean section rates or maternal-fetal risks

Scientific Justification: Labor induction affects 25% of pregnancies in France, with 70% requiring cervical ripening. While the 12-hour pose is standard, recent evidence suggests that shorter durations (6h) are effective but remain difficult to integrate into hospital workflows. Since the mechanical and physiological effects of the balloon are early phenomena, a 3-hour protocol could optimize bed management and patient comfort.

Strategy: Comparison between an experimental group (3-hour balloon pose followed by immediate active labor management regardless of Bishop score) and a control group (standard 12-hour balloon pose).

Follow-up: Participants are followed from the day of induction until hospital discharge (generally 2 to 10 days) to assess obstetric outcomes, neonatal safety, and maternal satisfaction.

Inclusion Criteria:

• Age ≥ 18 years,
• singleton pregnancy
• ≥ 34 weeks of gestation,
• cephalic presentation,
• Bishop score < 6,
• healthy uterus,
• standard indication for labor induction

Exclusion Criteria:

• Minor patients,
• ruptured membranes,
• twin pregnancy,
• fetal malpresentation,
• placenta previa,
• previous uterine scar,
• known fetal malformation