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Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)
Hemorrhage remains the leading cause of maternal death worldwide. Tranexamic acid has been shown to reduce rates of hemorrhage when given prophylactically prior to cesarean delivery. It has also been shown to be an effective treatment in response to hemorrhage after a vaginal delivery. The aim of this study is to assess the impact of TXA on hemorrhage rates when given prophylactically prior to all deliveries.
Hemorrhage remains the leading cause of maternal mortality worldwide. In a 2014 systematic analysis of the causes of maternal death, the World Health Organization (WHO) noted that even in the face of interventions developed to actively manage the third stage of labor, 27.1% of maternal deaths were directly attributable to excessive blood loss. Risk factors for postpartum hemorrhage (PPH) have been identified, but the majority of cases occur in low risk women. As such, the routine use of oxytocin in the third stage of labor is recommended in all women and has been well documented to reduce the risk of excessive blood loss. Uterotonics such as methylergonovine, 15-methyl PGF2α and misoprostol have shown to be particularly useful adjuncts as decreased uterine tone is the most common etiology of blood loss. More recently, tranexamic acid (TXA) has been shown to be efficacious in the prevention of postpartum hemorrhage in certain cohorts. Tranexamic acid exerts its effect through the binding of plasmin and subsequent inhibition of fibrin degradation. It is regarded as pregnancy category B by the Food and Drug Administration (FDA).
Age
18 - 54 years
Sex
FEMALE
Healthy Volunteers
Yes
Navy Medical Center
San Diego, California, United States
Start Date
April 20, 2018
Primary Completion Date
June 1, 2019
Completion Date
September 1, 2019
Last Updated
January 26, 2024
Tranexamic Acid 1000 mg/10ml normal saline infusion
DRUG
Lead Sponsor
United States Naval Medical Center, San Diego
NCT07034924
NCT05290129
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05245227