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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic Acid; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Senegal
  • Thiès, Senegal
    • Centre de santé 10ème de Thiès
  • Thiès, Senegal
    • Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène
• Vietnam
  • Hanoi, Vietnam
    • National Ob-Gyn Hospital
  • Ho Chi Minh City, Vietnam
    • Hung Vuong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; 1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol	Drug: Tranexamic Acid; Drug: Misoprostol
Placebo Comparator: Placebo; oral placebo + 800 mcg sublingual misoprostol	Drug: Placebo; Drug: Misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm	20 minutes after initial study treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of severe PPH	Rate of severe PPH (>1000 ml total blood loss)	2 hours after delivery
Mean/median blood loss		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)	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	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])	2 hours after delivery
Proportion of women who received additional drugs	Proportion of women who receive additional drugs	2 hours after delivery
Proportion of women who receive additional intervention	Proportion of women who receive additional interventions (i.e. suturing)	2 hours after delivery
Adverse events	Proportion of women who experience an adverse event	48 hours after delivery
Proportion of women who experience side effects	Proportion of women who experience side effects	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	48 hours after delivery

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Center for Research and Consultancy in Reproductive Health
• Investigators: Principal Investigator: Jill Durocher, Gynuity Health Projects; Principal Investigator: Nguyen Thi Nhu Ngoc, MD, MsC, CRCRH; Principal Investigator: Ayisha Diop, MPH, Gynuity Health Projects

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Gastrointestinal Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Tranexamic Acid; Misoprostol
• Other Study ID Numbers: 3006