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New study tests if popping the last membrane gets labour going faster

NCT ID NCT07301957

Knowledge-focused Sponsor: Centre Hospitalier le Mans Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

About 1 in 4 women have their water break before labour starts. Most go into labour within 48 hours, but some need to be induced. This study tests whether deliberately breaking the leftover membrane when a woman is admitted to the hospital can shorten the time to labour and reduce the need for induction. The trial will include 130 women with a single baby in head-down position.

What this could mean

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

Active substance
additional rupture of the residual membrane using a sterile amniotic membrane piercer (Robé device)
What this could lead to
If it works, this could reduce the time women wait for labour to start and lower the need for induced labour after their water breaks.
What could go wrong
This is a small, early-stage study with only 130 participants. It may not show a clear benefit, and the procedure carries a small risk of infection or discomfort.

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 130 people

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

Started

Mar 2026

Expected to finish

Mar 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 years and older

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: * Women over 18 years of age * Single foetal pregnancy, cephalic presentation * diagnosis of membrane rupture with persistence of one membrane and absence of immediate spontaneous labour. * Person affiliated with or beneficiary of a social security scheme * Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research). Exclusion Criteria: * Minor patient * patient under guardianship/curatorship, * multiple pregnancy, pregnancy with foetal death * non-cephalic presentation * gestational age less than 37 weeks, * rupture of membranes more than 12 hours ago * contraindication to vaginal deliver * meconium-stained amniotic fluid, * clinical signs suggestive of intrauterine infection (maternal hyperthermia \>38°C, maternal and/or foetal tachycardia, purulent amniotic fluid), * cervix not accessible for artificial rupture * vaginismus * contraindication to a potential expectant management * indication for induction for another reason

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Conditions

The condition(s) this trial relates to.

Fetal Membranes, Premature Rupture preterm premature rupture of the membranes

As listed by the trial registrant

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

Prelabor rupture of membranes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

  • CHU Angers

    RECRUITING

    Angers, 49000, France

  • Centre Hospitalier Le Mans

    RECRUITING

    Le Mans, 72000, France

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