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Could a 3-Hour balloon speed up labor induction?

NCT ID NCT07689357

Disease control Sponsor: Rambam Health Care Campus Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial compares two durations of cervical ripening balloon placement—3 hours versus the standard 12 hours—in pregnant women undergoing labor induction. The goal is to see if a shorter balloon time reduces the overall time from insertion to delivery while maintaining safety and comfort. Participants are randomly assigned to one of the two groups, and outcomes like delivery time, mode of delivery, and maternal satisfaction are tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cook Cervical Ripening Balloon
What this could lead to
If successful, this could make labor induction faster and more comfortable for pregnant women, reducing the time from balloon insertion to delivery.
What could go wrong
This is a small, early-stage trial, so results may not apply to all women. Shorter balloon placement might not effectively ripen the cervix, potentially leading to longer labor or more interventions.

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 164 people

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

Started

May 2026

Expected to finish

Nov 2028

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 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Nulliparous or multiparous pregnant women. * Gestational age between 37 0/7 and 41 6/7 weeks of gestation. * Maternal age between 18 and 45 years. * Participant has provided signed informed consent. Exclusion Criteria: * Presence of any contraindications for vaginal delivery. * Multifetal gestation. * Rupture of membranes prior to balloon insertion. * Favorable cervix, defined as a Bishop score greater than 6. * Cervical dilation greater than 2 cm. * Previous cesarean delivery or any other prior major uterine surgery.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical ripening and induction of labor Labor induction

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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 31906, Israel

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