Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Gynuity Health Projects
Collaborator:
Center for Research and Consultancy in Reproductive Health