NCT02805426

Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

Double-blind, Randomized Controlled Trial to Assess the Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm). The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each). The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid
DRUG	Placebo
DRUG	Misoprostol

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-06-20
• Last updated: 2018-02-19

Locations

4 sites across 2 countries: Senegal, Vietnam