Dilapan-S Versus Double Balloon Catheter (CRB) for Preinduction of Labor at Term

NANot yet recruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

December 31, 2026

Conditions
Induction of Labor
Interventions
DEVICE

Higroscopic Cervical ripening

Participants assigned to the Dilapan-S group will have 3 to 5 rods inserted under aseptic conditions. Placement will follow manufacturer instructions, and rods will remain in place for up to 12 hours unless spontaneous labor or device expulsion occurs earlier. Upon removal, cervical status will be assessed, and induction will continue with prostaglandins or oxytocin based on standard care.

DEVICE

Cervical ripening via CRB

Double Balloon Catheter (CRB) Participants randomized to CRB will undergo insertion of a double balloon catheter with inflation of each balloon (approximately 80 mL saline each) according to established protocols. The catheter will remain for up to 12 hours or until spontaneous labor or expulsion. Post-removal management will mirror that of the Dilapan-S group.

All Listed Sponsors
lead

University of Roma La Sapienza

OTHER