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Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement

NCT07689357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-07-08

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.

The main questions it aims to answer are:

Does placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?

Does a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?

Researchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.

Participants will:

Sign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).

Undergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.

Have the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.

Proceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.

Complete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.

Conditions

  • Labor Induction
  • Cervical Ripening and Induction of Labor

Interventions

DEVICE

Cook Cervical Ripening Balloon 3 hours

Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours.

DEVICE

Cook Cervical Ripening Balloon 12 hours

Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2028-06-01
Completion
2028-11-01
FDA Device
Yes

Countries

  • Israel

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 NCT07689357 on ClinicalTrials.gov