Membrane Stripping for Cervical Ripening

Not Applicable

Recruiting

• Conditions: Labor, Induced; Cervical Ripening; Balloon Induction; Membrane Stripping; Pregnancy Related
• Interventions: Device: Double Baloon Catheter; Procedure: Membrane Stripping

• Registration Number: NCT06591247
• Lead Sponsor: Meir Medical Center

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Study First Submitted: 2024-08-07
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-07
• Last Update Submitted: 2024-09-07
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 is contraindicated
• Twin pregnancies
• Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated
• Vaginal deliveries after a cesarean section
• Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Balloon Catheter induction	Double Baloon Catheter	A Double balloon catheter will be inserted for 12 hours in this group of women
Membrane stripping	Membrane Stripping	This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours

Primary Outcome Measures

Name	Time	Method
Rates of successful cervical ripening at the end of 12 hours, duration of cervical ripening	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 Outcome Measures

Name	Time	Method
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	What percentage of the women in this arm delivered within 24 hours

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, HaMerkaz, Israel