Using Tranexamic Acid to Prevent Postpartum Hemorrhage
Official title: Prevention of Postpartum Hemorrhage: Pharmacokinetics (PK) Abd Pharmacodynamics (PD) of Tranexamic Acid
Run by Inova Health Care Services · NCT05370820 · Data updated 2026-11-12
This study is testing if Tranexamic Acid can help prevent heavy bleeding after childbirth in women having cesarean sections or vaginal deliveries.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Inova Health Care Services Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | December 28, 2022 |
| Main results expected | October 1, 2027 |
| Study ends | April 1, 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05370820 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women over 34 weeks gestation scheduled for cesarean sections or vaginal deliveries, particularly those at high risk for hemorrhage.
✕Probably not a fit
Patients with active thrombotic diseases or a history of thromboembolic events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the use of Tranexamic Acid (TXA) to prevent postpartum hemorrhage in pregnant women undergoing cesarean sections and vaginal deliveries. It consists of two parts: the first part involves a dose-finding pharmacokinetic study with three different doses of TXA administered intravenously at the time of umbilical cord clamping. The second part compares the pharmacokinetic and pharmacodynamic endpoints of TXA administered via intravenous and intramuscular routes in high-risk patients. A total of 223 participants will be enrolled, including those undergoing cesarean sections and vaginal deliveries, with a control group receiving no TXA.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of postpartum hemorrhage, improving maternal health outcomes.
How similar studies have gone: Previous studies have shown promising results with TXA in reducing bleeding in surgical settings, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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George Washington University Hospital
Washington D.C., District of Columbia, United States Recruiting -
Inova Fairfax Medical Campus
Falls Church, Virginia, United States Recruiting
Study contacts
- Principal investigator: Homa K Ahmadzia, MD — Inova Health Care Services
- Study coordinator: Homa K Ahmadzia, MD
- Email: homa.ahmadzia@inova.org
- Phone: 706-776-6650
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating ultrasound to predict postpartum hemorrhage risk
This study is testing if ultrasound exams done shortly after delivery can help predict the risk of bleeding complications for new mothers in the hours following childbirth.
-
Predicting the risk of postpartum hemorrhage during childbirth
This study tests a new computer model that predicts the risk of heavy bleeding after childbirth to help doctors take better care of new moms.
-
Comparing carbetocin and oxytocin to prevent postpartum bleeding after cesarean delivery
This study is testing whether carbetocin works better than oxytocin to prevent heavy bleeding after a cesarean delivery in women who are at higher risk for this complication.
-
Point-of-care hemoglobin testing during pregnancy
This project will test non-invasive and finger-prick devices to see if they give accurate, immediate hemoglobin readings for pregnant people during prenatal visits.
-
Investigating how oxytocin works during cesarean deliveries
This study is testing how oxytocin works during scheduled cesarean deliveries to see if it helps prevent complications like uterine atony in new mothers.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.