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

Gynuity Health Projects260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

260

Conditions

Postpartum Hemorrhage

Interventions

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Centre de santé 10ème de Thiès

Thiès, Senegal

Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène

Thiès, Senegal

National OB-GYN Hospital

Hanoi, Vietnam

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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

Time frame: 20 minutes after initial study treatment

Secondary Outcomes

Rate of severe PPH

Rate of severe PPH (\>1000 ml total blood loss)

Time frame: 2 hours after delivery

Mean/median blood loss

Time frame: at two hours after treatment

Proportion of women with controlled bleeding

proportion of women with bleeding controlled at different time intervals (20, 40, 60, 120 mins)

Time frame: At various time intervals after study treatment (20, 40, 60, 120 mins)

Use of uterotonic agents after initial treatment

Proportion of women who are given uterotonic agents after initial treatment

Time frame: 2 hours after delivery

Proportion of women who received a serious interventions

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

Time frame: 2 hours after delivery

Proportion of women who received additional drugs

Proportion of women who receive additional drugs

Time frame: 2 hours after delivery

Proportion of women who receive additional intervention

Proportion of women who receive additional interventions (i.e. suturing)

Time frame: 2 hours after delivery

Adverse events

Proportion of women who experience an adverse event

Time frame: 48 hours after delivery

Proportion of women who experience side effects

Time frame: 2 hours after delivery

Proportion of women who find the treatment tolerable

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

Time frame: 48 hours after delivery