Prevention of Postpartum Hemorrhage With Tranexamic Acid
Completed · Phase 2
Conditions studied: Postpartum Hemorrhage
In brief
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 PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.
Key facts
- Study ID
- NCT03287336
- Run by
- George Washington University
- People needed
- 43
- Starts
- 2018-01-02
- Expected to finish
- 2023-09-30
- Last updated by the study team
- 2025-03-25
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- James Slota — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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