CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15,068 enrolled
Drug / intervention
Tranexamic Acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03475342
NCT03475342Phase 3Completed

Tranexamic Acid for the Prevention of Postpartum Bleeding in Women With Anaemia: an International, Randomised, Double-blind, Placebo Controlled Trial.

London School of Hygiene and Tropical Medicine·interventional·Posted Mar 23, 2018·Updated Jan 10, 2024

In Brief

A Phase 3 clinical trial evaluating Tranexamic Acid and Placebo for Intrapartum - Moderate and Severe Anaemia. Completed, enrolled 15,068 participants across 41 sites in 4 countries.

Detailed Summary

Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, almost all of which occur in low and middle income countries. When given within three hours of birth, tranexamic acid reduces deaths due to bleeding in women with PPH by almost one third. However, for many women, treatment of PPH is too late to prevent death and severe morbidities. Over one-third of pregnant women in the world are anaemic and many are severely anaemic. We now want to do the WOMAN-2 trial to see if giving tranexamic acid can prevent PPH and other severe outcomes in women with moderate and severe anaemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNigeria, Pakistan, Tanzania, Zambia

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMar 23, 2018
Enrollment StartAug 24, 2019
Primary CompletionSep 20, 2023
Study CompletionOct 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.3 years ago

Interventions

Tranexamic Aciddrug

Ampoules and packaging for both arms will be identical in appearance.

Placeboother

Ampoules and packaging for both arms will be identical in appearance.