DEVICE
Cook® double-balloon catheter
For both arms, the same double-balloon device is used. After the allocated time (3h or 12h) or spontaneous expulsion, active labor management is initiated, including early amniotomy and/or oxytocin administration
Status
Not yet recruiting
Phase
Not applicable
Enrollment
280
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DEVICE
For both arms, the same double-balloon device is used. After the allocated time (3h or 12h) or spontaneous expulsion, active labor management is initiated, including early amniotomy and/or oxytocin administration
Timeline
First posted
Mar 25, 2026
Study start
Mar 1, 2027
Primary completion
Mar 15, 2027
Study completion
Mar 15, 2027
Results posted
Not reported
Registry updated
Mar 31, 2026
Outcomes
induction-to-birth interval reduction
Time frame · balloon insertion and birth of the child
Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child
Not reported in the indexed record.
Eligibility
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
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
CH de Pau
Pau, France
Publications
No PMID-linked publications were present in this registry snapshot.
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