Prevention of Postpartum Hemorrhage With Tranexamic Acid

The study will enroll 45 additional third trimester pregnant women scheduled for nonemergent cesarean sections. The investigators plan to enroll 30, but to account for lost to follow-up, the investigators will enroll 45. The investigators will also enroll 30 pregnant patients > 34 weeks of gestation undergoing vaginal delivery, and 30 morbidly obese (BMI >= 40) pregnant patients undergoing either vaginal or cesarean delivery. However, the investigators will enroll 45 patients in each of these two groups to account for loss to follow up. The investigators will also enroll 45 patients as a control group that will not receive TXA. The total number of enrolled patients will thus be 223.

A total of 1 g of TXA will be administered to patients prior to fetal delivery via three different routes of administration: IV infusion, IV push, and IM injection. The subjects in each group will be divided into three subgroups:

Group 1: Up to 15 subjects, TXA dose: 1 g, Route: IV infusion over 10 minutes Group 2: Up to 15 subjects, TXA dose: 1 g, Route: IV Push for <2 minutes Group 3: Up to 15 subjects, TXA dose: 1 g, Route: IM Injection

Plasma sampling: Timing of samples will be relative to the end of drug administration (t = 0) and include: Pre-drug administration, 5-10 minutes, 30-60 minutes, 60-90 minutes, 1.5-3 hours, 3-4 hours, 4-5 hours, 7-8 hours, and 10-18 hours. Each volume of blood draw will be approximately 7-9 mL. Actual times of plasma sampling will be documented. A second IV will be required for participating in the study. Citrated plasma samples will be centrifuged and supernatant will be stored at -80 degree Celsius. Breast milk sampling of no more than 2 mL per time point will occur at time points coinciding with maternal feedings.

Inclusion criteria

• Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
• Women who are indicated to have a vaginal delivery at > 34+0 weeks gestation.
• Pregnant women with normal serum creatinine (serum creatinine < 0.9) within 2 weeks of estimated/scheduled delivery
• Women between the ages of 18 and 50 years old
• Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.

Exclusion criteria

• active thrombotic or thromboembolic disease
• a history of arterial or venous thromboembolic event
• inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy)
• a subarachnoid hemorrhage
• acquired defective color vision
• history of seizure disorder
• known renal dysfunction (serum creatinine = or >0.9)
• multiple gestations (twin or triplet pregnancies)
• hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
• history of liver dysfunction at the discretion of the investigator