Membrane Stripping for Cervical Ripening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double Baloon Catheter, Membrane Stripping, PGE2.
- Who it may be relevant to
- Registry conditions: Labor, Induced, Cervical Ripening, Balloon Induction, Membrane Stripping. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study
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.
Interventions
- Device Double Baloon Catheter
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study - Procedure Membrane Stripping
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) - Drug PGE2
A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours
Primary outcome measures
- 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]
Secondary outcome measures (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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT06591247 · 0067-23-MMC