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

NCT07492186 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-03-31

No results posted yet for this 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

Conditions

  • Induction of Childbirth

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier de PAU

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2027-03-15
Completion
2027-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492186 on ClinicalTrials.gov