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

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.

Timeline

Start

2016-10

Primary completion

2018-01

Completion

2018-01

Publications

• Diop A, Abbas D, Ngoc NTN, Martin R, Razafi A, Tuyet HTD, Winikoff B. A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage. Reprod Health. 2020 Mar 6;17(1):34. doi: 10.1186/s12978-020-0887-2.

Drugs

Indications

No indication recorded.