Prevention of Postpartum Hemorrhage With Tranexamic Acid

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 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.

Conditions

• Post Partum Hemorrhage

Interventions

DRUG

Tranexamic acid

Tranexamic Acid 1000 mg administered intravenously via infusion over 10 minutes.

DRUG

Tranexamic acid

Tranexamic Acid 1000 mg administered intravenously via push over 2 minutes.

DRUG

Tranexamic acid

Tranexamic Acid 1000 mg administered intramuscularly.

OTHER

No intervention

Control group with no administration of Tranexamic Acid.

Sponsors & Collaborators

• George Washington University

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Inova Health Care Services

  lead OTHER

Principal Investigators

• Homa K Ahmadzia, MD · Inova Health Care Services

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-28

Primary Completion

2026-11-15

Completion

2027-06-01

FDA Drug

Yes

Countries

• United States

Study Locations