Membrane Stripping for Cervical Ripening

Clalit Health Services

Status: Enrolling

Conditions: Labor, Induced; Balloon Induction; Cervical Ripening; Pregnancy Related; Membrane Stripping

Treatments: Device: Double Baloon Catheter; Procedure: Membrane Stripping

Study type: Interventional

Funder types: Other

Identifiers

NCT06591247

0067-23-MMC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Double Balloon Catheter induction

Active Comparator group

Description:

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

Treatment:

Device: Double Baloon Catheter

Membrane stripping

Active Comparator group

Description:

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

Treatment:

Procedure: Membrane Stripping