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Clinical Trials in France / NCT07492186
Starting soon Not applicable

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

NCT07492186 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier de PAU
Phase
Not applicable
Started
2027-03-01
Last updated
2026-03-31

Condition(s) studied

Induction of Childbirth

Investigational drug(s) / intervention(s)

Cook® double-balloon catheter

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

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
CH de Pau Pau France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07492186 on ClinicalTrials.gov ↗ ← All trials in France