Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-07
2026-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Double Balloon Catheter induction
A Double balloon catheter will be inserted for 12 hours in this group of women
Double Baloon Catheter
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
Membrane stripping
This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours
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)
Interventions
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Double Baloon Catheter
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
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)
Eligibility Criteria
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Inclusion Criteria
* Patients with a cervical dilation of at least 1 cm
* Full-term pregnancy
* Cephalic presentation
* No contraindication to vaginal delivery
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Gal Cohen
Gal Cohen MD, Principal Investigator
Locations
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Meir Medical Center
Kfar Saba, Central District, Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0067-23-MMC
Identifier Type: -
Identifier Source: org_study_id
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