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New study aims to find best way to induce labor when cervix Isn't ready

NCT ID NCT04949633

Symptom relief Sponsor: University Hospital, Tours 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study looks at two common ways to start labor in pregnant women whose cervix hasn't softened enough after 24 hours of preparation. One method uses the hormone oxytocin, and the other uses a different hormone called prostaglandins. The goal is to see which approach leads to fewer C-sections and shorter labor, while keeping mothers and babies safe. About 1,500 women will take part across multiple hospitals in France.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,494 people

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

Started

Sep 2021

Expected to finish

Nov 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 years and older

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: * Pregnant woman * ≥ 18 years old * With a singleton cephalic pregnancy * ≥37+0 weeks of gestation * Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation) * With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours * Bishop score ≤ 6 at inclusion (unfavorable cervix) * French health insurance policy holder * Written informed consent Exclusion Criteria: * Any measures of legal protection * Prior caesarean section or uterine scar * Contra-indications to a vaginal delivery * Foetus with suspected severe congenital abnormalities * Pathological foetal heart rate * Contra-indications to ANGUSTA® (oral misoprostol, cervical ripening agent) * Contra-indications to PROPESS® (vaginal slow releasing system of dinoprostone, cervical ripening agent) * Contra-indications to PROSTINE® (vaginal gel of dinoprostone, cervical ripening agent) * Contra-indications for using oxytocin * Woman in labor

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As listed by the trial registrant

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

Cervical ripening Unfavorable cervix

How to take part

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

  1. The places running it

    10 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

  • Gynaecology-obstetrics, Hospital St Joseph, Marseille

    TERMINATED

    Marseille, 13008, France

  • Gynaecology-obstetrics, Hospital, Pontoise

    NOT_YET_RECRUITING

    Pontoise, 95300, France

  • Gynaecology-obstetrics, Port Royal Maternity Hospital, Paris

    RECRUITING

    Paris, 75014, France

  • Gynaecology-obstetrics, University Hospital, Angers

    RECRUITING

    Angers, 49033, France

  • Gynaecology-obstetrics, University Hospital, Bordeaux

    TERMINATED

    Bordeaux, 33076, France

  • Gynaecology-obstetrics, University Hospital, Brest

    RECRUITING

    Brest, 29609, France

  • Gynaecology-obstetrics, University Hospital, Clermont-Ferrand

    TERMINATED

    Clermont-Ferrand, 63001, France

  • Gynaecology-obstetrics, University Hospital, Nancy

    RECRUITING

    Nancy, 54000, France

  • Gynaecology-obstetrics, University Hospital, Nantes

    RECRUITING

    Nantes, 44093, France

  • Gynaecology-obstetrics, University Hospital, Orléans

    RECRUITING

    Orléans, 45100, France

  • Gynaecology-obstetrics, University Hospital, Poitiers

    TERMINATED

    Poitiers, 86000, France

  • Gynaecology-obstetrics, University Hospital, Saint Etienne

    RECRUITING

    Saint-Etienne, 42270, France

  • Gynaecology-obstetrics, University Hospital, Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • Gynaecology-obstetrics, University Hospital, Tours

    RECRUITING

    Tours, 37044, France

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