Prevention of Postpartum Hemorrhage With Tranexamic Acid

Recruiting now · Phase 2

Conditions studied: Post Partum Hemorrhage

In brief

In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first. The drug was administered intravenously at the time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 g was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 ug/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition. In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1 g TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus \< 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery \> 34 weeks gestation, women undergoing vaginal delivery \> 34 weeks of gestation and morbidly obese women (BMI\>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigators also aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI \>= 40) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.

Key facts

Study ID: NCT05370820
Run by: Inova Health Care Services
People needed: 120
Starts: 2022-12-28
Expected to finish: 2027-06-01
Last updated by the study team: 2026-03-27

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

George Washington University Hospital — Washington D.C., District of Columbia, United States (enrolling)
Inova Fairfax Medical Campus — Falls Church, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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