Membrane Stripping for Cervical Ripening (Stripping)

April 10, 2026 updated by: Gal Cohen, Meir Medical Center

Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study

The goal of this interventional study is to evaluate the effectiveness of membrane stripping in cervical ripening compared to double balloon catheter induction.

The study population consists of women undergoing labor induction.

The main questions it aims to answer are:

  1. Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
  2. What is the influence of membrane stripping on the time required for cervical ripening, delivery duration, and maternal and fetal outcomes compared to balloon induction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
    • Central District
      • Kfar Saba, Central District, Israel, 4428164
        • Recruiting
        • Meir Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gal Cohen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18 and above
  • Patients with a cervical dilation of at least 1 cm
  • Full-term pregnancy
  • Cephalic presentation
  • No contraindication to vaginal delivery

Exclusion Criteria:

  • Patients with rupture of membranes
  • Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin
  • Patients for whom the use of a double-balloon catheter/PGE2 is contraindicated
  • Twin pregnancies
  • Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
  • Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double Balloon Catheter induction
A Double balloon catheter will be inserted for 12 hours in this group of women
Device: Double Baloon Catheter
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
Active Comparator: Membrane stripping
This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours
Procedure: Membrane Stripping
Stripping will be considered as 3-5 rotations of separating the amniotic sac from the cervix and will be perfomed twice (every 4-6 hours)
Active Comparator: PGE2 induction
This group of women will undergo cervical ripening using a vaginal PGE2 pessary
Drug: PGE2
A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening
Time Frame: from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months
What percentage of the women in this arm had a successful cervical ripening after 12 hours
from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of vaginal delivery within 24 hours
Time Frame: from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months
What percentage of the women in this arm delivered within 24 hours
from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

September 7, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0067-23-MMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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