Not Yet RecruitingNot Applicable

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

France280 participantsStarted 2027-03-01

Plain-language 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

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

induction-to-birth interval reduction

Timeframe: balloon insertion and birth of the child

Trial details

NCT IDNCT07492186

SponsorCentre Hospitalier de PAU

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-15

View on ClinicalTrials.gov More Induction of Childbirth trials