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WOMAN-2 trial (tranexamic acid in women with anaemia)

A large international trial in women with moderate or severe anaemia who gave birth vaginally. About 15,000 women were given either tranexamic acid or a dummy treatment (placebo) right after the birth, to see whether it prevents heavy bleeding. Neither the women nor the staff knew who got which. The medicine did not lower the risk of postpartum haemorrhage.

Also called WOMAN-2 · World Maternal Antifibrinolytic Trial_2

  • Study
  • In this atlas

Overview

Design
International, randomised, double-blind, placebo-controlled trial. Women were randomly assigned (1:1) after vaginal birth, by selecting the lowest-numbered treatment pack from a box of identical packs. Participants, care givers and outcome assessors were masked.
Phase
Phase 3
Enrolled
  • 15,068 women (registry enrollment, type ACTUAL) (enrolled count) (World Maternal Antifibrinolytic Trial_2, retrieved )
  • 7,580 women assigned to tranexamic acid (randomized count) (The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial, retrieved )
  • 7,488 women assigned to placebo (randomized count) (The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial, retrieved )
Sponsor
Not recorded
Funder
Registry
  • NCT NCT03475342
  • ISRCTN ISRCTN62396133
  • PACTR PACTR201909735842379
Started
(actual) (World Maternal Antifibrinolytic Trial_2, retrieved )
Primary completion
(actual) (World Maternal Antifibrinolytic Trial_2, retrieved )
Completion
(actual) (World Maternal Antifibrinolytic Trial_2, retrieved )
Countries
Nigeria, Pakistan, Tanzania, Zambia (World Maternal Antifibrinolytic Trial_2, retrieved )
Care setting
34 hospitals across four countries (Nigeria, Pakistan, Tanzania and Zambia). (The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

International, randomised, double-blind, placebo-controlled trial (2024; PMID 39461792) in 34 hospitals in Nigeria, Pakistan, Tanzania and Zambia. Registrations named in the paper: ISRCTN62396133, NCT03475342 and PACTR201909735842379. Registry enrolment is 15,068 (actual); the abstract gives 7580 randomised to tranexamic acid and 7488 to placebo. Lead sponsor on the registry: London School of Hygiene and Tropical Medicine (no organisation record in this atlas yet). The abstract names the Bill & Melinda Gates Foundation and the Wellcome Trust as funders; the registry lists both as collaborators. Primary outcome: clinically diagnosed primary postpartum haemorrhage within 24 hours of randomisation. Result: no reduction (risk ratio 1.05, 95% CI 0.94 to 1.19).

Arms

  • Tranexamic acid 1 g

    Intervention Tranexamic acid to prevent bleeding after birth

    1 g of tranexamic acid by slow intravenous injection over 10 minutes within 15 minutes of the umbilical cord being cut or clamped.

  • Matching placebo

    Intervention None named

    Matching placebo given in the same way.

Findings

No findings are published for this study.

Record details

Record id
maternal:woman-2-trial
Content hash
f19e7be50dfacddd32af0805402bf18fa901f8f85119d15836edfa47926f5ad6