NCT06591247

Brief Summary

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. 1.Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
  2. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2024

Longer than P75 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 Progress51%
Aug 2024Dec 2027

First Submitted

Initial submission to the registry

August 7, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

August 7, 2024

Last Update Submit

April 10, 2026

Conditions

Labor, InducedCervical RipeningBalloon InductionMembrane StrippingPregnancy RelatedInduction of Birth

Outcome Measures

Primary Outcomes (1)

  • Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening

    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 Outcomes (1)

  • Rates of vaginal delivery within 24 hours

    from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months

Study Arms (3)

Double Balloon Catheter induction

ACTIVE COMPARATOR

A Double balloon catheter will be inserted for 12 hours in this group of women

Device: Double Baloon Catheter

Membrane stripping

ACTIVE COMPARATOR

This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours

Procedure: Membrane Stripping

PGE2 induction

ACTIVE COMPARATOR

This group of women will undergo cervical ripening using a vaginal PGE2 pessary

Drug: PGE2

Interventions

PGE2DRUG

A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours

PGE2 induction
Double Baloon CatheterDEVICE

A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study

Double Balloon Catheter induction
Membrane StrippingPROCEDURE

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)

Membrane stripping

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Central District, 4428164, Israel

RECRUITING

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Gal Cohen, MD

CONTACT

+972545915788galcwork@gmail.com

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
Gal Cohen MD, Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

September 19, 2024

Study Start

August 7, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

IL(1)