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3-hour Versus 12-hour Double-balloon Catheter for Labor Induction
Sponsor: Centre Hospitalier de PAU
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
Official title: Labor Induction With Double-balloon Catheter Placed for 3 Hours Versus 12 Hours in Patients With an Indication for Induction: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2027-03-01
Completion Date
2027-03-15
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
CH de Pau
Pau, France