WOMAN trial (World Maternal Antifibrinolytic Trial)
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).
Also called WOMAN · World Maternal Antifibrinolytic Trial · WOrld Maternal ANtifibrinolytic Trial
- Study
- In this atlas
Overview
- 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
- 20,060 women
- 10,036 women in the tranexamic acid group
- 9,985 women in the placebo group
- Sponsor
- Not recorded
- Registry
-
ISRCTN76912190 -
NCT00872469 -
PACTR201007000192283
-
- Results reported in
- Started
- Primary completion
- (actual)
- Completion
- (actual)
- 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
- Care setting
- Hospitals. The paper reports 193 hospitals in 21 countries.
- Registry status
- “COMPLETED”
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.
Arms
-
Tranexamic acid plus usual care
Intervention Tranexamic acid for treating postpartum haemorrhage
1 g tranexamic acid by slow intravenous injection in addition to usual care. A second 1 g dose could be given if bleeding continued after 30 minutes or stopped and restarted within 24 hours of the first dose.
-
Placebo plus usual care
Intervention
Matching placebo (sodium chloride 0.9%) given the same way in addition to usual care, with the same option of a second dose.
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, and findings from different contexts are not combined.
In plain words
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).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
- 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.
- Hospitals (193 in the paper).
- 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.
- Postpartum, treated within hours of birth or later
- Gestational age Not reported
- Postnatal age Not reported
Maternal death due to bleeding Secondary endpoint
155 of 10,036 women in the Tranexamic acid plus usual care arm
- Measure
- Women who died of bleeding (count)
- Value
- 155 women
- Reported as
- 155 [1·5%] of 10 036
- Interval
- Not applicable
- Denominator
- n = 10,036
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
191 of 9,985 women in the Placebo plus usual care arm
- Measure
- Women who died of bleeding (count)
- Value
- 191 women
- Reported as
- 191 [1·9%] of 9985
- Interval
- Not applicable
- Denominator
- n = 9,985
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Tranexamic acid plus usual care compared with Placebo plus usual care
- Measure
- Risk ratio, tranexamic acid vs placebo, unadjusted (the paper also gives an adjusted ratio of 0.78, 95% CI 0.62 to 0.98)
- Value
- 0.81 ratio
- Reported as
- RR 0·81, 95% CI 0·65–1·00; p=0·045
- Interval
- 0.65 to 1
- Denominator
- Not applicable
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Caveats
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.
Sources and citations (6)
-
- Locator
- Results, Maternal death, para 1: bleeding deaths 155 and 191, risk ratio 0.81
- How it applies
- Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Abstract, Findings, sentence 2: death due to bleeding significantly reduced
- How it applies
- PubMed abstract of the same report.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
e734360d2becdd1091cac4214a571195ec245318bbcc57203b4aefce56222f3a- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Methods, Outcomes, para 1: death due to bleeding as the key secondary outcome
- How it applies
- Establishes the outcome role.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Methods, Statistical analysis, para 1: sample size increase and pre-specification before un-blinding
- How it applies
- Explains why this outcome was added and when.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Summary, Findings: adverse events did not differ significantly
- How it applies
- Safety context from the same trial.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
Background Department of Error (correction to the WOMAN trial report)
- Locator
- Erratum text: tranexamic acid concentration corrected in the procedures section
- How it applies
- The correction changes a drug concentration, not a result.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
4d208f181f5cdbc06acf1817fcc38b5c0f1aa32848784237eed45c1e13fbbf6d- Reuse basis
- PMC6891225 is open access under CC BY-NC-ND 4.0, as its own XML states. Short quotation with attribution; the XML is not committed.
In plain words
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.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
- 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.
- Hospitals (193 in the paper).
- Hospitals in 21 countries, as for the whole trial.
- Postpartum, within 3 hours of birth
- Gestational age Not reported
- Postnatal age Not reported
Maternal death due to bleeding Secondary endpoint
Tranexamic acid plus usual care arm
- Measure
- Women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)
- Value
- 89 women
- Reported as
- 89 [1·2%]
- Interval
- Not applicable
- Denominator
- Not reported
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Placebo plus usual care arm
- Measure
- Women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)
- Value
- 127 women
- Reported as
- 127 [1·7%]
- Interval
- Not applicable
- Denominator
- Not reported
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Tranexamic acid plus usual care compared with Placebo plus usual care
- Measure
- Risk ratio, tranexamic acid vs placebo, within 3 hours of birth (pre-specified subgroup)
- Value
- 0.69 ratio
- Reported as
- RR 0·69, 95% CI 0·52–0·91; p=0·008
- Interval
- 0.52 to 0.91
- Denominator
- Not applicable
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Caveats
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.
Sources and citations (8)
-
- Locator
- Results, Maternal death, para 3: 89 and 127 within 3 hours; 66 and 63 after 3 hours
- How it applies
- Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Abstract, Findings, sentence 2: especially within 3 hours of giving birth
- How it applies
- PubMed abstract of the same report.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
e734360d2becdd1091cac4214a571195ec245318bbcc57203b4aefce56222f3a- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Methods, Statistical analysis, para 3: homogeneity rule and overall relative risk
- How it applies
- The trial own rule for reading subgroups.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Figure 3 image, Time from delivery (h) block: group counts and the heterogeneity p value
- How it applies
- Figure image on the PMC figure page of the open-access version of record (CC BY-NC-ND 4.0), read by eye; the numbers are not in the XML.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
fe0cb41cfd6fbcbb55fc2536569de36ed1641ca9ce90f4310ef13db7d5241fcc- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Results, Maternal death, Figure 3 caption: the asterisk marks the heterogeneity p value
- How it applies
- Caption of the figure that holds the time-to-treatment test.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Methods, Statistical analysis, para 1: subgroup pre-specified before un-blinding
- How it applies
- Timing of the pre-specification.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
Background Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage
- Locator
- Recommendation 27, Remarks, bullet 4: timing evidence behind the 3-hour window
- How it applies
- WHO 2025 consolidated guideline, CC BY-NC-SA 3.0 IGO; short quotation with attribution.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
2049fb40dff7e97712c98cb58907ef662161627197a5e143ec50045abb1931de- Reuse basis
- Licensed CC BY-NC-SA 3.0 IGO, as stated in the PDF and in the IRIS record. Only short quotations with attribution are used, and neither the PDF nor the pages are committed. The non-commercial and share-alike terms need a licensing decision before any text is adapted.
-
Background Department of Error (correction to the WOMAN trial report)
- Locator
- Erratum text: tranexamic acid concentration corrected in the procedures section
- How it applies
- The correction changes a drug concentration, not a result.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
4d208f181f5cdbc06acf1817fcc38b5c0f1aa32848784237eed45c1e13fbbf6d- Reuse basis
- PMC6891225 is open access under CC BY-NC-ND 4.0, as its own XML states. Short quotation with attribution; the XML is not committed.
In plain words
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.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
- 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.
- Hospitals (193 in the paper).
- 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.
- Postpartum, treated within hours of birth or later
- Gestational age Not reported
- Postnatal age Not reported
Death from any cause Endpoint role not specified
227 of 10,036 women in the Tranexamic acid plus usual care arm
- Measure
- Women who died from any cause (count)
- Value
- 227 women
- Reported as
- 227 [2·3%]
- Interval
- Not applicable
- Denominator
- n = 10,036
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
256 of 9,985 women in the Placebo plus usual care arm
- Measure
- Women who died from any cause (count)
- Value
- 256 women
- Reported as
- 256 [2·6%]
- Interval
- Not applicable
- Denominator
- n = 9,985
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Tranexamic acid plus usual care compared with Placebo plus usual care
- Measure
- Risk ratio, tranexamic acid vs placebo, unadjusted
- Value
- 0.88 ratio
- Reported as
- RR 0·88, 95% CI 0·74–1·05; p=0·16
- Interval
- 0.74 to 1.05
- Denominator
- Not applicable
- Time window
- From randomisation to death, discharge or 42 days, whichever came first
Caveats
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.
Sources and citations (3)
-
- Locator
- Results, Maternal death, para 1: all-cause death 227 and 256, risk ratio 0.88
- How it applies
- Open-access version of record (CC BY-NC-ND 4.0), which carries the online correction of 5 May 2017.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
-
- Locator
- Discussion, para 2: why all-cause death is diluted
- How it applies
- The authors own reading of the result.
- Retrieved
- Source effective date
- Not reported
- Source state
- Corrected
- Snapshot hash
6a76b2d6a645ab133480bc533cf223870f0d4759de632b12b704fcf261daffe4- Reuse basis
- PMC5446563 is open access under CC BY-NC-ND 4.0, as its own XML states. Short factual extraction and short quotations with attribution (WOMAN Trial Collaborators, Lancet 2017;389:2105-2116, doi:10.1016/S0140-6736(17)30638-4); no adaptation. The XML is not committed because of the non-commercial term; only its sha256 is kept. The PubMed record is not committed either. The Figure 3 image (gr3.jpg from the PMC figure page, same licence) is not committed; only its sha256 is kept, and its numbers were read from the image by eye.
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Background Department of Error (correction to the WOMAN trial report)
- Locator
- Erratum text: tranexamic acid concentration corrected in the procedures section
- How it applies
- The correction changes a drug concentration, not a result.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
4d208f181f5cdbc06acf1817fcc38b5c0f1aa32848784237eed45c1e13fbbf6d- Reuse basis
- PMC6891225 is open access under CC BY-NC-ND 4.0, as its own XML states. Short quotation with attribution; the XML is not committed.
Record details
- Record id
maternal:woman-trial- Content hash
db252fae6cff1b61b9b98f9a6defa8c3f6541b516a4d882dc4143bcda34afa84