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

NCT02805426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-02-19

No results posted yet for this study

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.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Tranexamic Acid

DRUG

Placebo

DRUG

Misoprostol

Sponsors & Collaborators

  • Center for Research and Consultancy in Reproductive Health

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Jill Durocher · Gynuity Health Projects

  • Dina Abbas, MPH · Gynuity Health Projects

  • Nguyen thi Nhu Ngoc, MD, MSc · CRCRH

  • Ayisha Diop, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Senegal
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02805426 on ClinicalTrials.gov