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Simple finger sweep vs balloon: which gets labor started better?

NCT ID NCT06591247

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Meir Medical Center

    RECRUITING

    Kfar Saba, Central District, 4428164, Israel

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