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Labor drug pause may protect newborns

NCT ID NCT03991091

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether turning off the labor drug oxytocin once a woman reaches 6 cm dilation (active labor) could lower the chance of newborn complications. Over 2,400 women with a single, full-term baby in head-down position took part. The goal was to see if this simple change in drug timing could improve newborn health outcomes like breathing, blood acidity, and need for intensive care.

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

2,459 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2022

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: * With a term (≥37 WG) pregnancy * Singleton pregnancy * Fetus in cephalic presentation * Women receiving oxytocin during the latent phase of the 1st stage of labor, before 4 cm of cervical dilatation, including women with an induction of labor using cervical ripening or oxytocin * Speaking and reading French language * Affiliated to social security * Who have signed the consent form Exclusion Criteria: * Women with a scarred uterus * Fetus with a congenital anomaly * Fetal growth retardation \<3rd percentile * Having an abnormal fetal heart rate at randomization * Maternal age \< 18 years * Participating in another trial involving medication

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As listed by the trial registrant

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

Neonatal morbidity

Contacts and locations

Locations

  • hospital Cochin; port royal Maternity unit

    Paris, 75014, France

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