Actively Recruiting
Prevention of Postpartum Hemorrhage: Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Pregnant Women
Led by Inova Health Care Services · Updated on 2026-03-27
120
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
Sponsors
I
Inova Health Care Services
Lead Sponsor
G
George Washington University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of Tranexamic Acid (TXA) to prevent postpartum hemorrhage in pregnant women. This Phase 2 trial focuses on understanding the drug's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) when administered around the time of delivery. The study includes women scheduled for cesarean sections or vaginal deliveries after 34 weeks of pregnancy, including a group of morbidly obese women and a control group not receiving TXA. The study is divided into two parts. In part 1, different doses of TXA were given intravenously during cesarean delivery to find the optimal dose. Part 2 compares the effects of giving 1 gram of TXA by three different routes before cord clamping: intravenous infusion over 10 minutes, intravenous push in less than 2 minutes, and intramuscular injection. Participants include those undergoing cesarean or vaginal delivery and morbidly obese patients. A control group will receive no TXA. Participants will have blood samples taken at multiple time points up to 18 hours after drug administration to measure TXA levels and effects. Breast milk samples will also be collected during feeding times. Researchers will monitor blood loss during surgery and safety outcomes during hospital stay and up to 6 weeks postpartum. The study aims to understand how different administration methods impact drug levels and safety, with total enrollment planned for 223 women.
CONDITIONS
Brief Title
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women scheduled for medically indicated cesarean section after 34 weeks gestation or elective cesarean at 39 weeks
- Women scheduled for vaginal delivery after 34 weeks gestation
- Pregnant women with normal serum creatinine (less than 0.9) within 2 weeks of delivery
- Women aged 18 to 50 years old
- Ability to understand and sign informed consent and HIPAA authorization
You will not qualify if you...
- Active thrombotic or thromboembolic disease
- History of arterial or venous thromboembolic event
- Inherited thrombophilia or conditions increasing clot risk (e.g., lupus, antiphospholipid syndrome)
- Subarachnoid hemorrhage
- Acquired defective color vision
- History of seizure disorder
- Known renal dysfunction (serum creatinine 0.9 or higher)
- Multiple gestations (twins or triplets)
- Hypersensitivity to Tranexamic Acid or antifibrinolytic therapy
- History of liver dysfunction as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment during delivery
Participants receive a 1 g dose of Tranexamic Acid administered prior to fetal delivery by one of three routes: IV infusion over 10 minutes, IV push over less than 2 minutes, or intramuscular injection. Blood and breast milk samples are collected at specified times relative to drug administration for pharmacokinetic and pharmacodynamic analyses.
1 administration visit with multiple blood and breast milk sample collections
Duration - Up to 6 weeks postpartum
Participants are monitored for safety parameters during surgery, after surgery while in the hospital, and at 2 weeks and 6 weeks postpartum.
Approximately 3 post-delivery visits (during hospital stay, 2 weeks postpartum, 6 weeks postpartum)
Trial Site Locations
Total: 2 locations
1
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
2
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
H
Homa K Ahmadzia, MD
J
Jaclyn Phillips
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here