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C-Section bleeding breakthrough: tranexamic acid tested on 4,500 women

NCT ID NCT03431805

Disease control Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study tested whether giving tranexamic acid right after a cesarean delivery can prevent postpartum hemorrhage, or dangerous heavy bleeding. Over 4,500 women participated across multiple hospitals. The drug was given as a single injection after the umbilical cord was clamped, alongside standard care. The main goal was to see if it reduced the number of women who lost more than 1 liter of blood or needed a blood transfusion.

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 effective, this could become a standard preventive treatment to reduce dangerous bleeding after cesarean delivery.
What could go wrong
The trial is completed but results may not apply to all women, and there is a small risk of blood clots or seizures with tranexamic acid.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

4,574 people

The number who actually took part.

Started

Mar 2018

Finished

Apr 2020

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 64 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: * : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks, * hemoglobin level at the last blood sample \>9g/dl, * available blood test for Hb and Ht within one week before caesarean delivery, * informed signed consent Exclusion Criteria: * previous thrombotic event or preexisting pro-thrombotic disease, * epileptic state or history of seizures, * presence of any chronic or active cardiovascular disease outside hypertension, * any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease, * sickle cell disease, * placenta praevia, * placenta accreta/increta/percreta, * abruption placentae, * eclampsia, * HELLP syndrome, * significant hemorrhage before cesarean section * in utero fetal death, * administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery, * planned general anesthesia, * hypersensitivity to tranexamic acid or concentrated hydrochloric acid, * instrumental extraction failure, * multiple pregnancy with vaginal delivery of the first child, * poor understanding of the French language.

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

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

Postpartum hemorrhage

Contacts and locations

Locations

  • CH de Pau

    Pau, France

  • CHRU Côte de Nacre

    Caen, 14033, France

  • CHRU de Nancy

    Nancy, 54000, France

  • CHU Angers

    Angers, 49033, France

  • CHU Bordeaux

    Bordeaux, 33076, France

  • CHU Charles Nicolle

    Rouen, 76000, France

  • CHU Estain

    Clermont-Ferrand, 63001, France

  • CHU Jean Minjoz

    Besançon, 25000, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Nîmes

    Nîmes, 30900, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU Saint Etienne

    Saint-Etienne, 42270, France

  • CHU Strasbourg

    Strasbourg, 67098, France

  • CHU Tours

    Tours, 37044, France

  • CHU de Montpellier

    Montpellier, 34295, France

  • Centre Hospitalier Intercommunal Poissy-Saint Germain

    Poissy, 78303, France

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, France

  • Hopital Nord

    Marseille, 13915, France

  • Hôpital Paule de Viguier CHU Toulouse

    Toulouse, 31059, France

  • Hôpital Saint Joseph Marseille

    Marseille, 13008, France

  • Hôpital Saint Joseph Paris

    Paris, 75014, France

  • Hôpital Trousseau

    Paris, 75012, France

  • Hôpital universitaire Kremlin-Bicètre

    Paris, 94270, France

  • Hôpital universitaire Necker-Enfants malades

    Paris, 75015, France

  • Hôpital universitaire Robert Debré

    Paris, 75019, France

  • Maternité de Port-Royal Paris

    Paris, 75014, France

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