Current partner codePEPTIDESDE
NCT07492186·Not applicable·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Not applicable

Enrollment

280

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Mar 25, 2026

  2. Study start

    Mar 1, 2027

  3. Primary completion

    Mar 15, 2027

  4. Study completion

    Mar 15, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Mar 31, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
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

Study locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

CH de Pau

Pau, France

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.