Labor, InducedStrippingNCT06591247
Membrane Stripping for Cervical Ripening
A study testing Double Baloon Catheter, Membrane Stripping and PGE2 in people with Labor, Induced and Cervical Ripening, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Induced, Cervical Ripening, Balloon Induction
- What is being tested?
- Double Baloon Catheter, Membrane Stripping and PGE2
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Central District, 4428164
Gal - Cohen, MD, +972545915788, galcwork@gmail.com
Renana Izakson, MD, +972506511297, renana.izakson@gmail.com
About this study
Official title: Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study
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:
- Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
- 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.
- Conditions
- Labor, Induced, Cervical Ripening, Balloon Induction, Membrane Stripping, Pregnancy Related, Induction of Birth
- Being tested
- Double Baloon Catheter, Membrane Stripping, PGE2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Baloon CatheterDevice
A double Baloon Catheter will be inserted for 12 hours to one of the arms of the study
Membrane StrippingProcedure or surgery
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)
PGE2Drug
A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours
| Study group | Role | What they receive |
|---|---|---|
| Double Balloon Catheter induction | Active comparator | A Double balloon catheter will be inserted for 12 hours in this group of women Receives: Device: Double Baloon Catheter |
| Membrane stripping | Active comparator | This group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours Receives: Procedure: Membrane Stripping |
| PGE2 induction | Active comparator | This group of women will undergo cervical ripening using a vaginal PGE2 pessary Receives: Drug: PGE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 12 hours after intervention until patient&s discharge or 150 hours, whichever came first, assessed up to 100 months
Secondary outcomes (1)
Rates of vaginal delivery within 24 hours
What percentage of the women in this arm delivered within 24 hours
Measured: from 12 hours after intervention until patients discharge or 150 hours, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Aug 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Cohen, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591247
- Sponsor's protocol ID
- 0067-23-MMC
- Acronym
- Stripping
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06591247
- Acronym / sponsor ID
- Stripping / 0067-23-MMC
- Conditions
- Labor, Induced, Cervical Ripening, Balloon Induction, Membrane Stripping, Pregnancy Related, Induction of Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is membrane stripping as effective as double balloon catheter induction in cervical ripening?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double Balloon Catheter induction | Active comparator | Device: Double Baloon CatheterA Double balloon catheter will be inserted for 12 hours in this group of women |
| Membrane stripping | Active comparator | Procedure: Membrane StrippingThis group of women will undergo membrane stripping twice (every 4-6 hours) over a period of 12 hours |
| PGE2 induction | Active comparator | Drug: PGE2This group of women will undergo cervical ripening using a vaginal PGE2 pessary |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Baloon CatheterA double Baloon Catheter will be inserted for 12 hours to one of the arms of the study | Device | Double Balloon Catheter induction |
| Membrane StrippingStripping will be considered as 3-5 rotations of separating the amniotic sac from the cervix and will be perfomed twice (every 4-6 hours) | Procedure or surgery | Membrane stripping |
| PGE2A PGE2 vaginal pessary (Cervidil) will be inserted for 12-24 hours | Drug | PGE2 induction |
Primary outcome
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
What percentage of the women in this arm had a successful cervical ripening after 12 hours
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Baloon Catheter, Membrane Stripping and PGE2 in people with Labor, Induced and Cervical Ripening, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gal Cohen, MD (+972545915788, galcwork@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.