About the trial

WOMAN-2

Aim:

To determine the effect of tranexamic acid  (TXA) on postpartum bleeding in women with moderate or severe anaemia.

Background:

Postpartum haemorrhage (PPH) is responsible for about 100,000 maternal deaths every year, most of which occur in low and middle income countries. TXA reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. TXA decreases blood loss in surgery and reduces death due to bleeding after trauma. When given within three hours of birth, TXA reduces deaths due to bleeding in women with PPH. 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 design:

A randomised, double-blind, placebo controlled trial.

Population:

10, 000 women with moderate or severe anaemia who give birth vaginally.

Setting:

The trial will be conducted in hospitals where anaemia in pregnancy is common in Africa and Asia.

WOMAN-2 Trial Protocol:

 

http://www.isrctn.com/ISRCTN62396133

https://clinicaltrials.gov/ct2/show/NCT03475342

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