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NCT Number: NCT06591247

Membrane Stripping for Cervical Ripening

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.

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Key information

Conditions

Labor, Induced Balloon Induction Cervical Ripening Induction of Birth Membrane Stripping Pregnancy Related

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Baloon Catheter

Device

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

Membrane Stripping

Procedure

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)

PGE2

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Gal Cohen, MD

CONTACT

[email protected]

+972545915788

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study

Acronym: Stripping

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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