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New study aims to stop Post-Birth bleeding with smarter drug dosing

NCT ID NCT05370820

Prevention Sponsor: Inova Health Care Services Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 looks at how to best use the drug tranexamic acid (TXA) to prevent postpartum hemorrhage (severe bleeding after childbirth). Researchers will test different doses and ways of giving the drug (by IV or injection) in about 120 women having a C-section or vaginal delivery. The goal is to find the safest and most effective dose to prevent dangerous bleeding.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

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 50 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: * Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists * Women who are indicated to have a vaginal delivery at \> 34+0 weeks gestation. * Pregnant women with normal serum creatinine (serum creatinine \< 0.9) within 2 weeks of estimated/scheduled delivery * Women between the ages of 18 and 50 years old * Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization. Exclusion Criteria: * active thrombotic or thromboembolic disease * a history of arterial or venous thromboembolic event * inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy) * a subarachnoid hemorrhage * acquired defective color vision * history of seizure disorder * known renal dysfunction (serum creatinine = or \>0.9) * multiple gestations (twin or triplet pregnancies) * hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy * history of liver dysfunction at the discretion of the investigator

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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.

Post partum hemorrhage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • George Washington University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Inova Fairfax Medical Campus

    RECRUITING

    Falls Church, Virginia, 22042, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.