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Could a higher oxytocin dose reduce C-Sections in obese women?

NCT ID NCT04760496

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether giving a higher dose of oxytocin (a drug that strengthens contractions) could lower the rate of C-sections in obese women having their first baby. Over 400 women took part, receiving either a standard or a higher dose during labour. The goal was to see if the higher dose helps labour progress better and reduces the need for surgery.

What this could mean

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

Active substance
Oxytocin
What this could lead to
If successful, this could lead to a simple change in oxytocin dosing to reduce C-sections in obese women during labour.
What could go wrong
This is a completed Phase 4 trial, but results may not apply to all hospitals or populations. Higher oxytocin doses also carry risks like excessive contractions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

443 people

The number who actually took part.

Started

Oct 2021

Finished

Jan 2025

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 Inclusion criteria are the following: * Age ≥ 18 years * Nulliparous (no previous childbirth beyond 22 SA) * BMI ≥ 30 kg/m² at the beginning of pregnancy * Singleton pregnancy * Spontaneous or induced onset of labour * Cephalic presentation * Term ≥ 37 weeks of gestation and \< 42 weeks of gestation * Medical Indication and absence of medical contraindication for oxytocin during labour: inadequate and/or ineffective uterine contraction and/or delayed cervical dilation * Written consent * Affiliation to a french social security system Exclusion criteria Exclusion criteria are the following: * Hypersensitivity to the active substance (oxytocin), to any of its excipients or to latex (risk of cross allergy) * Medical contraindication for oxytocin * Coagulation disorders * Foetal growth restriction (inferior to 5th percentile) * Foetal malformation (major) * Foetal heart rate anomalies before use of oxytocin (at the time of inclusion) * History of uterine surgery (scarred uterus of gynaecological origin) * Patient with a disease requiring caesarean section prior to labour (planned caesarean section before labour) * Severe renal failure * Patient deprived of their liberty (under curatorship or guardianship) * Participation in another interventional trial of category 1. Patients included in interventional research with minimal risk and constraints may participate in the study after the investigator's assessment.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

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

OBESE Oxytocin Primiparous women

Contacts and locations

Locations

  • CHU d'Angers

    Angers, France

  • CHU de Bordeaux (Pellegrin)

    Bordeaux, France

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nimes

    Nîmes, France

  • CHU de Poissy St Germain

    Poissy, France

  • CHU de Saint Etienne

    Saint-Etienne, France

  • CHU de Strasbourg (Centre Médico Chirurgical et Obstétrical)

    Schiltigheim, France

  • CHU de Strasbourg (Hôpital de Hautepierre)

    Strasbourg, France

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Béclère

    Clamart, France

  • Hôpital Cochin Port Royal

    Paris, France

  • Hôpital Tenon

    Paris, France

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