WOMAN-2

Overview

The WOMAN-2 Trial is a randomised, double-blind, placebo-controlled trial that investigated whether giving tranexamic acid (TXA) 15 minutes after the umbilical cord being clamped after birth could prevent clinical diagnose postpartum haemorrhage (PPH) in women with moderate or severe anaemia who gave birth vaginally. The trial took place in Nigeria, Pakistan, Tanzania and Zambia.

Trial background

PPH is responsible for about 70,000 maternal deaths every year, most of which occur in low- and middle-income countries. TXA reduces blood loss in surgery and trauma, and when given within three hours of birth, it decreases PPH-related deaths. However, many women receive PPH treatment too late. Over one-third of pregnant women globally are anaemic, increasing their risk and severity of PPH. There is an urgent need for a safe and effective method to reduce postpartum bleeding in anaemic women.

However, for many women, treatment of PPH is too late to prevent death. Over one-third of pregnant women in the world are anaemic and many are severely anaemic. These women have an increased risk of PPH and suffer more severe outcomes if PPH occurs. There is an urgent need to identify a safe and effective way to reduce postpartum bleeding in anaemic women.

Trial in numbers

15,068

Participants recruited

4 Recruiting countries

34 Hospitals

Results

Anaemic women have a greatly increased risk of PPH. The more severe the anaemia, the higher the risk of PPH and the sooner after birth the diagnosis is made. And as their haemoglobin levels fall, their risk of death and serious complications, including antepartum haemorrhage, abruption and stillbirth increases.

The trial, which published its results in October 2024, found that giving women with moderate or severe anaemia tranexamic acid (TXA) within fifteen minutes of the umbilical cord being cut or clamped did not reduce the risk of clinically diagnosed PPH. And it might be too late to prevent severe bleeding in many women, so randomised trials of earlier treatment are needed.

There was no evidence of an increase in thromboembolic or treatment related adverse events with the use of TXA.

The WOMAN Trials Collaborators also published an individual patient data (IPD) meta-analysis, which assessed data on 54,404 women across five clinical trials and found that TXA substantially reduces life-threatening bleeding after childbirth, regardless of the type of birth (vaginal or caesarean) or the presence or absence of anaemia. The analysis showed that TXA cut the risk of life-threatening bleeding by nearly one quarter.