Induction of Childbirth
Conditions
Brief 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
Detailed description
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
DEVICECook® 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
Sponsors
Centre Hospitalier de PAU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Multicenter, randomized, open-label, superiority trial with two parallel arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction-to-birth interval reduction | 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 |
Countries
France
Outcome results
None listed