# WOMAN trial (World Maternal Antifibrinolytic Trial)

Study · id `maternal:woman-trial` · Maternal & Newborn Atlas · release `15708f235d73cd42` (public)

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Also called: WOMAN; World Maternal Antifibrinolytic Trial; WOrld Maternal ANtifibrinolytic Trial

Browse, life stage: Postpartum  

## In plain language

A large trial that tested whether tranexamic acid, added to usual care, helps women who are bleeding heavily after giving birth. About 20 000 women in 193 hospitals in 21 countries took part. Neither the women nor the staff knew who got the medicine and who got a dummy injection (placebo).

## Technical summary

International, randomised, double-blind, placebo-controlled trial of women aged 16 years and older with a clinical diagnosis of PPH after vaginal birth or caesarean section. Registrations ISRCTN76912190, NCT00872469 and PACTR201007000192283. Enrolled 20 060 women (ClinicalTrials.gov count; the paper prints 20 060). Analysed numbers differ by table and are never added: 10 036 and 9985 for the death-by-cause analysis (Table 2), and 10 032 and 9985 for the primary composite (Table 3). The structured enrollment list holds the enrolled count and the analysed counts of the two groups for the death-by-cause analysis (10 036 and 9985) as separate entries, never added together. The 10 032 of Table 3 is not an enrollment entry: it is the denominator of the primary composite analysis, which is a claim-only result. The primary outcome was death from any cause or hysterectomy within 42 days of randomisation; death due to bleeding was the key secondary outcome. The planned sample of 15 000 was raised to 20 000 during the trial, because hysterectomy decisions were often made at the same time as randomisation. Dates differ by source and are shown side by side: ClinicalTrials.gov gives a start of 2009-05, a primary completion of 2016-06 and a completion of 2017-04; ISRCTN gives recruitment from 2009-03-01 to 2016-05-30 and an overall end date of 2016-05-30; the paper says women were enrolled between March 2010 and April 2016. Sponsor: London School of Hygiene and Tropical Medicine (no organisation record yet). Funders named in the abstract: that school, Pfizer, the UK Department of Health, the Wellcome Trust and the Gates Foundation. Pfizer made the trial tranexamic acid. The paper names 21 countries. The structured country list holds all 21, including the Democratic Republic of Congo. The registries list different sets of countries.

## Key facts

- Design: International, randomised, double-blind, placebo-controlled, parallel-group trial in 193 hospitals. Women were allocated by choosing a numbered treatment pack from a box of eight packs that were identical apart from the number. Participants, caregivers and outcome assessors were masked. Analysis was by intention to treat, with complete cases and no imputation.
- Phase: Phase 3
- Enrolled: 20060 women (enrolled count; World Maternal Antifibrinolytic Trial, snapshot `maternal:ctgov-nct00872469-2026-10-11`, retrieved 2026-10-11); 10036 women in the tranexamic acid group (analyzed count; Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial, snapshot `maternal:pmc-pmc5446563-2026-10-11`, retrieved 2026-10-11); 9985 women in the placebo group (analyzed count; Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial, snapshot `maternal:pmc-pmc5446563-2026-10-11`, retrieved 2026-10-11)
- Started: 2009-05 (World Maternal Antifibrinolytic Trial, snapshot `maternal:ctgov-nct00872469-2026-10-11`, retrieved 2026-10-11)
- Primary completion: 2016-06 (actual) (World Maternal Antifibrinolytic Trial, snapshot `maternal:ctgov-nct00872469-2026-10-11`, retrieved 2026-10-11)
- Completion: 2017-04 (actual) (World Maternal Antifibrinolytic Trial, snapshot `maternal:ctgov-nct00872469-2026-10-11`, retrieved 2026-10-11)
- Countries: Nigeria; Pakistan; Uganda; Kenya; Cameroon; Sudan; United Kingdom; Tanzania; Nepal; Zambia; Albania; Bangladesh; Ethiopia; Burkina Faso; Jamaica; Ghana; Papua New Guinea; Egypt; Colombia; Côte d’Ivoire; Congo - Kinshasa (Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial, snapshot `maternal:pmc-pmc5446563-2026-10-11`, retrieved 2026-10-11)
- Care setting: Hospitals. The paper reports 193 hospitals in 21 countries. (Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial, snapshot `maternal:pmc-pmc5446563-2026-10-11`, retrieved 2026-10-11)
- Registry status: "COMPLETED" (ClinicalTrials.gov, snapshot `maternal:ctgov-nct00872469-2026-10-11`, retrieved 2026-10-11)

## Study findings

Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero.

### In the WOMAN trial, women with heavy bleeding after birth who were given tranexamic acid were less likely to die of bleeding than women given a placebo. 155 of 10 036 women (1.5%) died of bleeding with tranexamic acid, against 191 of 9985 (1.9%) with placebo. The risk ratio was 0.81 (95% confidence interval 0.65 to 1.00, p=0.045). The authors named death due to bleeding as the key secondary outcome. The upper end of the interval touches 1.00, and the primary outcome, death from any cause or hysterectomy, did not differ clearly between the groups (separate claim).

Claim `maternal:claim-woman-death-due-to-bleeding`.

Source problem: a cited source is corrected. Check the sources before relying on this claim.

Applies to: Recipient: Maternal; Population: Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage after a vaginal birth or caesarean section. WOMAN specified that the diagnosis could rest on clinically estimated blood loss of more than 500 mL after vaginal birth or 1000 mL after caesarean section, or any blood loss sufficient to compromise haemodynamic stability. This is the trial eligibility wording, not a WHO definition. The fundamental eligibility criterion was the clinician uncertainty about whether to use tranexamic acid in that woman. The overall result covers every treatment time.; Care setting: Hospitals (193 in the paper).; Geography: Hospitals in 21 countries. The paper site list names Nigeria, Pakistan, Uganda, Kenya, Cameroon, Sudan, United Kingdom, Tanzania, Nepal, Zambia, Albania, Democratic Republic of Congo, Bangladesh, Ethiopia, Burkina Faso, Jamaica, Ghana, Papua New Guinea, Egypt, Colombia and Cote d'Ivoire.; Life stage: Postpartum, treated within hours of birth or later; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first.

Limitations: Death due to bleeding is a cause-specific secondary outcome. The primary composite showed no clear difference. The upper confidence bound is 1.00. The planned sample of 15 000 was raised to 20 000 during the trial to estimate this effect, after hysterectomy decisions were found to be often made at the time of randomisation. The authors state that they pre-specified this outcome and the time-to-treatment subgroups before un-blinding. Clinicians recorded the immediate cause of death, the main cause if there were several. The trial was double-blind. The paper also gives an adjusted risk ratio of 0.78 (95% CI 0.62 to 0.98). Adverse events, including thromboembolic events, did not differ significantly between groups in WOMAN. Pfizer is among the funders and made the trial drug. Analysed numbers are those printed for this analysis (10 036 and 9985); some randomised women were excluded from analysis and the paper prints no total. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.

- Maternal death due to bleeding (Secondary): Women who died of bleeding (count) 155 women; reported as "155 \[1·5%\] of 10 036"; arm Tranexamic acid plus usual care, no comparator arm; interval Not applicable; denominator 10036 (Printed in the paper as 10 036 women analysed in the tranexamic acid group. Never add it to the placebo group figure; the paper prints no total.); time window From randomisation to death, discharge or 42 days, whichever came first
- Maternal death due to bleeding (Secondary): Women who died of bleeding (count) 191 women; reported as "191 \[1·9%\] of 9985"; arm Placebo plus usual care, no comparator arm; interval Not applicable; denominator 9985 (Printed in the paper as 9985 women analysed in the placebo group. Never add it to the other group figure; the paper prints no total.); time window From randomisation to death, discharge or 42 days, whichever came first
- Maternal death due to bleeding (Secondary): Risk ratio, tranexamic acid vs placebo, unadjusted (the paper also gives an adjusted ratio of 0.78, 95% CI 0.62 to 0.98) 0.81 ratio; reported as "RR 0·81, 95% CI 0·65–1·00; p=0·045"; arm Tranexamic acid plus usual care compared with Placebo plus usual care; interval 0.65 to 1 (95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows above); time window From randomisation to death, discharge or 42 days, whichever came first

### Among women in WOMAN who were given tranexamic acid within 3 hours of giving birth, 89 died of bleeding against 127 given placebo, a risk ratio of 0.69 (95% CI 0.52 to 0.91, p=0.008). When treatment came after 3 hours the counts were 66 and 63, a risk ratio of 1.07 (95% CI 0.76 to 1.51, p=0.70). This is a pre-specified subgroup analysis of the secondary outcome, not the primary result. The trial stated its own rule. Unless the test for different effects across subgroups gave p below 0.001, the overall relative risk (0.81 for death due to bleeding) was regarded as the most reliable guide to subgroup effects. Figure 3 of the paper gives p=0.085 for the test of different effects across the three time-from-delivery groups (up to 1 hour, over 1 to 3 hours, over 3 hours). That is above the trial bar of 0.001, so by the trial rule the overall relative risk of 0.81 stays the better guide. Because earlier trauma data gave strong reason to expect a time effect, the authors also planned to read the timing result alongside all available data on that effect.

Claim `maternal:claim-woman-within-3h`.

Source problem: a cited source is corrected. Check the sources before relying on this claim.

Applies to: Recipient: Maternal; Population: The subgroup of WOMAN women treated within 3 hours of giving birth. The trial pre-specified subgroup analyses of death due to bleeding by the time interval between giving birth and treatment, as a protocol change made before un-blinding. The same eligibility applies as for the whole trial. The comparison with later treatment is given in the same claim.; Care setting: Hospitals (193 in the paper).; Geography: Hospitals in 21 countries, as for the whole trial.; Life stage: Postpartum, within 3 hours of birth; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first.

Limitations: The p=0.085 in Figure 3 tests three time groups together, not the within-3-hours split alone, and the paper text gives no heterogeneity result for time to treatment on this outcome. Figure 5 of the paper sets WOMAN beside CRASH-2 results and has its own heterogeneity p value; this record did not read it. Figure 3 prints separate denominators for the up to 1 hour and over 1 to 3 hours groups and no combined within-3-hours denominator. WHO 2025 Recommendation 27 remarks rest the 3-hour window on WOMAN timing analysis and on a pooled individual-participant analysis of 40 138 bleeding patients, which includes WOMAN participants and trauma patients. Death due to bleeding is a cause-specific secondary outcome and the primary composite was not clearly reduced. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.

- Maternal death due to bleeding (Secondary): Women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup) 89 women; reported as "89 \[1·2%\]"; arm Tranexamic acid plus usual care, no comparator arm; interval Not applicable; denominator Not reported (basis: The paper prints no combined within-3-hours denominator. Figure 3 splits the window into up to 1 hour and over 1 to 3 hours, each with its own denominators, so this record leaves the denominator empty and never adds them.); time window From randomisation to death, discharge or 42 days, whichever came first
- Maternal death due to bleeding (Secondary): Women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup) 127 women; reported as "127 \[1·7%\]"; arm Placebo plus usual care, no comparator arm; interval Not applicable; denominator Not reported (basis: The paper prints no combined within-3-hours denominator. Figure 3 splits the window into up to 1 hour and over 1 to 3 hours, each with its own denominators, so this record leaves the denominator empty and never adds them.); time window From randomisation to death, discharge or 42 days, whichever came first
- Maternal death due to bleeding (Secondary): Risk ratio, tranexamic acid vs placebo, within 3 hours of birth (pre-specified subgroup) 0.69 ratio; reported as "RR 0·69, 95% CI 0·52–0·91; p=0·008"; arm Tranexamic acid plus usual care compared with Placebo plus usual care; interval 0.52 to 0.91 (95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows above); time window From randomisation to death, discharge or 42 days, whichever came first

### In WOMAN, 227 women given tranexamic acid (2.3%) and 256 given placebo (2.6%) died from any cause, a risk ratio of 0.88 (95% CI 0.74 to 1.05, p=0.16). The difference was not statistically significant. The authors note that more than a quarter of deaths were not due to bleeding, which dilutes any effect on all-cause death, and that the effect on death due to bleeding is the more generalisable measure.

Claim `maternal:claim-woman-all-cause-death`.

Source problem: a cited source is corrected. Check the sources before relying on this claim.

Applies to: Recipient: Maternal; Population: Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage after a vaginal birth or caesarean section. WOMAN specified that the diagnosis could rest on clinically estimated blood loss of more than 500 mL after vaginal birth or 1000 mL after caesarean section, or any blood loss sufficient to compromise haemodynamic stability. This is the trial eligibility wording, not a WHO definition. The fundamental eligibility criterion was the clinician uncertainty about whether to use tranexamic acid in that woman. The overall result covers every treatment time.; Care setting: Hospitals (193 in the paper).; Geography: Hospitals in 21 countries. The paper site list names Nigeria, Pakistan, Uganda, Kenya, Cameroon, Sudan, United Kingdom, Tanzania, Nepal, Zambia, Albania, Democratic Republic of Congo, Bangladesh, Ethiopia, Burkina Faso, Jamaica, Ghana, Papua New Guinea, Egypt, Colombia and Cote d'Ivoire.; Life stage: Postpartum, treated within hours of birth or later; Gestational age: Not reported; Postnatal age: Not reported; Follow-up: Outcome data were collected at death, discharge or 42 days after randomisation, whichever came first.

Limitations: All-cause death was assessed separately from the primary composite and is not named as a secondary outcome in the methods, so its endpoint role is not specified. The mix of bleeding and non-bleeding deaths varies by region and hospital, so the authors say the all-cause effect is not generalisable. Denominators are 10 036 and 9985 as printed, and the paper prints no total. Source correction: the Lancet printed a correction to this paper (a Department of Error notice; the online article was corrected on 5 May 2017). It changes one number in the procedures section, the tranexamic acid concentration, from 10 mg/mL to 100 mg/mL. The correction notice lists this one change and no other, and the text read for this claim is the corrected text. The source state shows Corrected for that reason.

- Death from any cause (Not specified): Women who died from any cause (count) 227 women; reported as "227 \[2·3%\]"; arm Tranexamic acid plus usual care, no comparator arm; interval Not applicable; denominator 10036 (Printed in the paper as 10 036 women analysed in the tranexamic acid group. Never add it to the placebo group figure; the paper prints no total.); time window From randomisation to death, discharge or 42 days, whichever came first
- Death from any cause (Not specified): Women who died from any cause (count) 256 women; reported as "256 \[2·6%\]"; arm Placebo plus usual care, no comparator arm; interval Not applicable; denominator 9985 (Printed in the paper as 9985 women analysed in the placebo group. Never add it to the other group figure; the paper prints no total.); time window From randomisation to death, discharge or 42 days, whichever came first
- Death from any cause (Not specified): Risk ratio, tranexamic acid vs placebo, unadjusted 0.88 ratio; reported as "RR 0·88, 95% CI 0·74–1·05; p=0·16"; arm Tranexamic acid plus usual care compared with Placebo plus usual care; interval 0.74 to 1.05 (95% confidence interval); denominator Not applicable (basis: Comparison of the two per-arm rows above); time window From randomisation to death, discharge or 42 days, whichever came first

## Connected pages

- Tests tranexamic acid added to usual care: Tranexamic acid for treating postpartum haemorrhage (`maternal:tranexamic-acid-pph-treatment`)
- Enrolled women with a clinical diagnosis of postpartum haemorrhage: Postpartum haemorrhage (`maternal:postpartum-hemorrhage`)
- Key secondary outcome: Maternal death due to bleeding (`maternal:outcome-maternal-death-due-to-bleeding`)
- Reports death from any cause: Death from any cause (`core:outcome-death-any-cause`)
- Funder named in the abstract: Bill & Melinda Gates Foundation (`maternal:gates-foundation`)
- Primary results, Lancet 2017: WOMAN primary results, Lancet 2017 (`maternal:pub-woman-lancet-2017`)

## Provenance

Content hash: db252fae6cff1b61b9b98f9a6defa8c3f6541b516a4d882dc4143bcda34afa84
Last substantive edit: 2026-10-12
Evidence last checked: 2026-10-11