Status:
COMPLETED
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Lead Sponsor:
George Washington University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PP...
Detailed Description
Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be ...
Eligibility Criteria
Inclusion
- Women who are undergoing medically indicated cesarean section at greater than 34+0 weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
- Pregnant women with normal serum creatinine (serum creatinine \< 0.9)
- Women between the ages of 18 and 50 years old
Exclusion
- Patients younger than 18 or older than 50
- women with active thrombotic or thromboembolic disease
- Women with a history of arterial or venous thromboembolic event
- Women with inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
- Women with a subarachnoid hemorrhage
- Women with acquired defective color vision
- history of seizure disorder
- known renal dysfunction
- multiple gestations (Twin or triplet pregnancies)
- Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
- History of liver dysfunction
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03287336
Start Date
January 2 2018
End Date
September 30 2023
Last Update
March 25 2025
Active Locations (1)
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1
James Slota
Washington D.C., District of Columbia, United States, 20037