Prevention of Postpartum Hemorrhage With Tranexamic Acid

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Homa Ahmadzia
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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