NCT07492186

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Mar 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

14 days

First QC Date

March 19, 2026

Last Update Submit

March 26, 2026

Conditions

Induction of Childbirth

Outcome Measures

Primary Outcomes (1)

  • induction-to-birth interval reduction

    Time (in hours) between the effective initiation of labor induction (balloon insertion) and the birth of the child

    balloon insertion and birth of the child

Study Arms (2)

3-hour pose

EXPERIMENTAL

3-hour pose of the Cook® double-balloon catheter

Device: Cook® double-balloon catheter

12-hour pose (standard care)

ACTIVE COMPARATOR

12-hour pose of the Cook® double-balloon catheter (standard care)

Device: Cook® double-balloon catheter

Interventions

Cook® double-balloon catheterDEVICE

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

12-hour pose (standard care)3-hour pose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years,
  • singleton pregnancy
  • ≥ 34 weeks of gestation,
  • cephalic presentation,
  • Bishop score \< 6,
  • healthy uterus,
  • standard indication for labor induction

You may not qualify if:

  • Minor patients,
  • ruptured membranes,
  • twin pregnancy,
  • fetal malpresentation,
  • placenta previa,
  • previous uterine scar,
  • known fetal malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Pau

Pau, 64000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Multicenter, randomized, open-label, superiority trial with two parallel arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)