Using Tranexamic Acid to Prevent Postpartum Hemorrhage

Prevention of Postpartum Hemorrhage: Pharmacokinetics (PK) Abd Pharmacodynamics (PD) of Tranexamic Acid

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
• Enrollment: 120 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Inova Health Care Services (Academic / other)
• Locations: 2 sites (Washington D.C., District of Columbia and 1 other locations)
• Trial ID: NCT05370820 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with active thrombotic diseases or a history of thromboembolic events may not benefit from this study.

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 performed: Previous studies have shown promising results with TXA in reducing bleeding in surgical settings, suggesting potential success for this approach.

Eligibility 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 this trial is running

Washington D.C., District of Columbia and 1 other locations

• 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

Conditions Post Partum Hemorrhage