Prevention of Postpartum Hemorrhage With Tranexamic Acid (Phase 3)
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
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 gram was administered. TXA serum levels at several time points after delivery
were assayed to see if they reach the target plasma concentration of 10 microg/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 1000
mg 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 greater than 34 weeks gestation,
women undergoing vaginal delivery > 34 weeks of gestation and morbidly obese women (BMI>50)
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 investigatorsalso aim to enroll 30
patients undergoing vaginal delivery and 30 morbidly obese women (BMI > 50) 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.