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Massive trial tests cheap drug to stop Post-C-Section hemorrhage

NCT ID NCT03364491

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large study tested whether giving tranexamic acid (TXA) during C-sections can prevent severe bleeding. Over 11,000 women received either TXA or a placebo right after delivery. The goal was to see if TXA reduces the need for blood transfusions or death. Results could change how doctors manage bleeding risks in cesarean births.

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 (TXA)
What this could lead to
If effective, this could make C-sections safer by reducing the need for blood transfusions and preventing severe bleeding.
What could go wrong
This trial is complete, but results may not apply to all women. TXA carries a small risk of blood clots, which was monitored closely.

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

11,000 people

The number who actually took part.

Started

Mar 2018

Finished

Oct 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 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: 1. Scheduled or unscheduled cesarean delivery 2. Singleton or twin gestation Exclusion Criteria: 1. Age less than 18 years 2. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage 3. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated 4. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis 5. Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures 6. Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions. 7. Sickle cell disease, because of substantial use of perioperative transfusion unrelated to hemorrhage. Sickle cell trait is not an exclusion per se. 8. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism 9. Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA 10. Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA 11. Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA 12. Patient refusal of blood products because the primary outcome is then pre-determined 13. Receipt of TXA; or planned or expected use of TXA prophylaxis 14. Active cancer, because of risk of thromboembolism 15. Congestive heart failure requiring treatment, because of risk of thrombosis 16. History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA 17. Acquired defective color vision or subarachnoid hemorrhage, since TXA is contraindicated 18. Hypersensitivity to TXA or any of the ingredients 19. No hemoglobin result available from the last 4 weeks, since it is necessary to measure the post-operative change in hemoglobin 20. Scheduled cesarean delivery and quota for scheduled deliveries already met. Quotas on the number of scheduled and unscheduled deliveries will be placed to ensure approximately equal distribution of scheduled and unscheduled cesarean deliveries. 21. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included. 22. Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism 23. Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis 24. Symptomatic for COVID-19 infection within 14 days prior to delivery

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Brown University

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve-MetroHealth

    Cleveland, Ohio, 44109, United States

  • Columbia University

    New York, New York, 10032, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Northwestern University-Prentice Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State University Hospital

    Columbus, Ohio, 43210, United States

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35233, United States

  • University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas - Houston

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132, United States

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