drugset / Trial / NCT03287336
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Phase 2
Completed
43 enrolled
George Washington University
National Center for Advancing Translational Sciences (NCATS) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSequentialSingle-blindPrevention
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 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.
Timeline
- Start
- 2018-01-02
- Primary completion
- 2023-09-01
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 5 mg/kg | Intravenous |
| Subject | Tranexamic Acid | Small molecule | 10 mg/kg | Intravenous |
| Subject | Tranexamic Acid | Small molecule | 15 mg/kg | Intravenous |
Indications
No indication recorded.