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Drug combo aims to stop Post-Birth bleeding, but trial stopped early

NCT ID NCT01113229

Prevention 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 two drugs—oxytocin and misoprostol—together could prevent postpartum hemorrhage (heavy bleeding) after vaginal birth better than oxytocin alone. The trial planned to include over 1,700 women giving birth at 36 to 42 weeks, but it was terminated early, so we don't have full results. The goal was to reduce the number of women losing more than 500 mL of blood within an hour of delivery.

What this could mean

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

Active substance
oxytocin and misoprostol
What this could lead to
If it worked, this combination could offer a better way to prevent dangerous bleeding after childbirth, saving lives and reducing complications.
What could go wrong
The trial was terminated early, so results are incomplete. The combination may not be more effective than oxytocin alone and could carry added side effects like nausea or fever.

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

1,721 people

The number who actually took part.

Start date

Mar 2010

Finished

Dec 2014

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: * Women\>18 years, * during first stage of normal labor, * at 36 to 42 weeks, * with epidural analgesia and informed signed consent Exclusion Criteria: * Cesarean section delivery, * clotting disorders, * prostaglandin allergy, * absent consent.

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Conditions

The condition(s) this trial relates to.

Hemorrhage Postpartum Hemorrhage

As listed by the trial registrant

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

Hemorrhage; complicating delivery

Contacts and locations

Locations

  • Chi Poissy St Germain

    Poissy, 78300, France