NCT07689357

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress8%
May 2026Nov 2028

Study Start

First participant enrolled

May 27, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Labor InductionCervical Ripening and Induction of Labor

Outcome Measures

Primary Outcomes (1)

  • Insertion-to-Delivery Time Interval

    The time interval (in hours) from the successful insertion of the cervical ripening balloon to the time of fetal delivery (whether vaginal or cesarean section).

    From the time of balloon insertion up to delivery (approximately 48 hours).

Secondary Outcomes (5)

  • Mode of Delivery

    At the time of delivery.

  • Time to Active Phase and Second Stage of Labor

    From balloon insertion up to delivery, assessed up to 48 hours after balloon insertion.

  • Maternal Complications

    From balloon insertion up to 48 hours postpartum.

  • Adverse Neonatal Outcomes

    From birth up to newborn discharge or 7 days of life.

  • Duration of Hospitalization

    From admission for induction up to hospital discharge (approximately 3-5 days).

Study Arms (2)

3 hours balloon group

EXPERIMENTAL

Double-balloon cervical ripening catheter inserted and left in place for 3 hours before removal

Device: Cook Cervical Ripening Balloon 3 hours

12 hours balloon group

ACTIVE COMPARATOR

Double-balloon cervical ripening catheter inserted and left in place for 12 hours before removal

Device: Cook Cervical Ripening Balloon 12 hours

Interventions

Cook Cervical Ripening Balloon 3 hoursDEVICE

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.

3 hours balloon group
Cook Cervical Ripening Balloon 12 hoursDEVICE

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.

12 hours balloon group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based strictly on biological sex (pregnant individuals with an unfavorable cervix requiring labor induction)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparous or multiparous pregnant women.
  • Gestational age between 37 0/7 and 41 6/7 weeks of gestation.
  • Maternal age between 18 and 45 years.
  • Participant has provided signed informed consent.

You may not qualify if:

  • Presence of any contraindications for vaginal delivery.
  • Multifetal gestation.
  • Rupture of membranes prior to balloon insertion.
  • Favorable cervix, defined as a Bishop score greater than 6.
  • Cervical dilation greater than 2 cm.
  • Previous cesarean delivery or any other prior major uterine surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31906, Israel

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 8, 2026

Study Start

May 27, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

July 8, 2026

Record last verified: 2026-07

Locations

IL(1)