NCT03326596

Prevention of Postpartum Hemorrhage With TXA

Prevention of Postpartum Hemorrhage With Tranexamic Acid (TXA)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: United States Naval Medical Center, San Diego · Federal
• Sex: Female
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 1000 mg/10ml normal saline infusion	Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant

Timeline

• Start date: 2018-04-20
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2017-10-31
• Last updated: 2024-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study