Prevention of Postpartum Hemorrhage With Tranexamic Acid

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03287336
Study type	Interventional
Source	George Washington University
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 2, 2018
Completion date	November 1, 2023

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