NCT03287336

Prevention of Postpartum Hemorrhage With Tranexamic Acid

Prevention of Postpartum Hemorrhage: Identifying Pregnant Women at Risk and Determining the Safe and Effective Use of Tranexamic Acid Using State-of-the-art Pharmacokinetic/Pharmacodynamics Modeling

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.

Timeline

• Start date: 2018-01-02
• Primary completion: 2023-09-01
• Completion: 2023-09-30
• First posted: 2017-09-19
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study