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

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

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.

Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm

Serious intervention is defined as blood transfusion, interventions for tissue repair, surgical intervention [including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature])

Proportion of women who find the procedure tolerable and acceptable as indicated in an acceptability scale

Inclusion Criteria: Women who delivery vaginally Women who experience PPH defined as blood loss ≥700ml Women capable of giving consent Exclusion Criteria: Clear contraindication for tranexamic acid such as known allergy or thromboembolic event during pregnancy Women delivering via cesarean section Provider feels that the woman, at presentation for delivery, is not in a position to give appropriate informed consent

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.