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Can a common drug make C-Sections safer? new trial tests lower dose

NCT ID NCT02797119

Disease control Sponsor: University Hospital, Lille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two doses of tranexamic acid (a drug that helps blood clot) to see if it could reduce blood loss during cesarean deliveries when heavy bleeding occurs. 225 women who experienced significant bleeding during a planned or non-emergency C-section were randomly given either a standard dose, a half-dose, or a placebo. The goal was to find the best balance between stopping bleeding and avoiding side effects.

What this could mean

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

Active substance
tranexamic acid
What this could lead to
If successful, this could help doctors choose the safest effective dose of tranexamic acid to reduce dangerous bleeding during C-sections.
What could go wrong
This is a completed Phase 4 trial with 225 participants, so results are reliable but may not apply to all types of bleeding or emergency C-sections.

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

225 people

The number who actually took part.

Started

Mar 2016

Finished

Apr 2021

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 to 60 years

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: Experimental group: Each patient * experiencing a bleeding volume of more than 800 mL * due to surgery or to atony uterine * during an elective or non-emergent caesarean section * secondary post-partum haemorrhage after caesarean section, even if CS has been emergent * after complete information and consent signature. * covered by social security. Reference non-hemorrhagic group: Each patient * experiencing a bleeding volume of strictly less than 800 mL * during an elective or emergent caesarean section * after complete information and consent signature. * covered by social security. Exclusion Criteria: Patient unable to consent (\<18 years old or incapable people and specially protected mentioned in the article L1121-5 to L1121-8) RCP medical contraindication to tranexamic acid such as * Hypersensibility to the product or excipient, * Previous or ongoing arterial or venous thrombosis, * Coagulopathy, except DIC associated with a predominant fibrinolytic profile, * Renal failure, * Previous seizures, * intrathecal or intraventricular administration. Obstetrical contraindication to TA * Severe HELLP syndrome (platelet count \<50 000/m3 or renal failure prior to the caesarean (RIFLE score\>2) Protocol related contraindication to inclusion * Administration of TA before inclusion-Inherited haemorrhagic diseases and low molecular weight heparin within 24 hours before inclusion * Patients who participated in a study on the efficacy of an experimental drug in the two month preceding the caesarean section * Inherited haemorrhagic diseases or low molecular weight heparin within 24 hours before inclusion * Previous inclusion in an interventional trial since the 2 months before CS

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Conditions

The condition(s) this trial relates to.

Hemorrhage pregnancy disorder

As listed by the trial registrant

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

Hemorrhage Pregnancy complications

Contacts and locations

Locations

  • Assistance Publique Hôpitaux Paris Hôpital Louis Mourier

    Paris, France

  • Assistance Publique Hôpitaux Paris Hôpital Trousseau

    Paris, France

  • Centre Hospitalier Maternité Monaco Valenciennes

    Valenciennes, France

  • Hospices civils de Lyon CHU-Lyon Croix Rousse

    Lyon, France

  • Hôpital Jeanne de Flandre - CHRU de Lille

    Lille, France

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