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Midwife-Led care may reduce unnecessary medical interventions in childbirth

NCT ID NCT05483101

Knowledge-focused Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 597 women with low-risk pregnancies to see if a special midwife-led care unit (called Filière Physiologique) leads to more natural births compared to standard hospital care. The special unit offers personalized support from a midwife throughout pregnancy and birth, while still being inside a hospital for emergencies. The goal was to see if this approach reduces the need for tools or C-sections and improves the overall birth experience.

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.

Participants

597 people

The number who actually took part.

Started

Sep 2022

Finished

Jul 2023

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.

Who is studied

Women who planned to give birth in a maternity hospital involved in the study, with a low risk pregnancy

Ages

18 to 40 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: * Low-risk pregnancy according to the HAS clinical practice recommendations (2016): follow-up classified A (without particularity) provided indifferently by a FS or a physician; eligibility if follow-up classified A1 or A2 after advice from an ob-gyn and/or another specialist. * Gestational age between 34 and 39 weeks of amenorrhea * Single pregnancy * Maternal age ≥ 18 et \< 40 years old * Patient who planned to give birth in a maternity hospital involved in the study. * Having been informed about the protocol and not having expressed opposition to participate in the PhysioCare study. Non-inclusion criteria: * Psychiatric history or depression with medication * Anonymous childbirth * History of caesarean section * Undeclared pregnancy, not or poorly followed up (no blood/urinary check-ups carried out during pregnancy and/or no monthly follow-up with medical consultation) * Couples unable to speak French * Non-affiliation of patient to a social security scheme * Adult persons subject to legal protection ; persons deprived of their liberty Exclusion Criteria: * Fetal death or medical termination of pregnancy after inclusion * Death of the child at birth * Premature birth \< 37 weeks of age

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As listed by the trial registrant

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

Compare 2 models of midwifery care in maternity care

Contacts and locations

Locations

  • Centre Hospitalier Simone Veil

    Eaubonne, 95600, France

  • Clinique Mutualiste La Sagesse

    Rennes, 35000, France

  • Rennes University Hospital

    Rennes, 35000, France