Membrane Stripping for Cervical Ripening

Meir Medical Center200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Labor, Induced Cervical Ripening Balloon Induction Membrane Stripping Pregnancy Related

Interventions

Double Baloon CatheterDEVICE

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

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months

Secondary Outcomes

Rates of vaginal delivery within 24 hours

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

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