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Simple finger sweep vs balloon: which gets labor started better?
NCT ID NCT06591247
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a simple procedure called membrane stripping (where a doctor sweeps a finger around the cervix to separate the amniotic sac) works as well as a balloon catheter to ripen the cervix before inducing labor. About 400 full-term pregnant women will be randomly assigned to receive either membrane stripping, a double balloon catheter, or a hormone pessary. The main goal is to see how many women have a successfully ripened cervix after 12 hours.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Membrane stripping (procedure), double balloon catheter (device), PGE2 vaginal pessary (drug)
- What this could lead to
- If membrane stripping works as well as the balloon catheter, it could offer a simpler, less invasive option to prepare the cervix for labor induction.
- What could go wrong
- This is a single-center study with 400 participants, so results may not apply to all women. Membrane stripping may be less effective or cause discomfort compared to other methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Meir Medical Center
RECRUITINGKfar Saba, Central District, 4428164, Israel
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