{
  "release_id": "15708f235d73cd42",
  "id": "maternal:woman-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "woman-trial",
  "name": "WOMAN trial (World Maternal Antifibrinolytic Trial)",
  "aliases": [
    "WOMAN",
    "World Maternal Antifibrinolytic Trial",
    "WOrld Maternal ANtifibrinolytic Trial"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "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).",
  "summary_technical": "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.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-12",
  "last_evidence_check": "2026-10-11",
  "next_review_due": null,
  "external_ids": [
    {
      "namespace": "isrctn",
      "value": "ISRCTN76912190"
    },
    {
      "namespace": "nct",
      "value": "NCT00872469"
    },
    {
      "namespace": "pactr",
      "value": "PACTR201007000192283"
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "postpartum"
      ]
    }
  },
  "payload": {
    "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.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct00872469-2026-10-11"
      }
    ],
    "start_date": {
      "date": "2009-05",
      "type": null,
      "snapshot": "maternal:ctgov-nct00872469-2026-10-11"
    },
    "primary_completion_date": {
      "date": "2016-06",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00872469-2026-10-11"
    },
    "completion_date": {
      "date": "2017-04",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00872469-2026-10-11"
    },
    "countries": [
      {
        "code": "NG",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "PK",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "UG",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "KE",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "CM",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "SD",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "GB",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "TZ",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "NP",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "ZM",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "AL",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "BD",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "ET",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "BF",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "JM",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "GH",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "PG",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "EG",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "CO",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "CI",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "code": "CD",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      }
    ],
    "care_setting": {
      "description": "Hospitals. The paper reports 193 hospitals in 21 countries.",
      "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 20060,
        "basis": "enrolled",
        "unit": "women",
        "snapshot": "maternal:ctgov-nct00872469-2026-10-11"
      },
      {
        "count": 10036,
        "basis": "analyzed",
        "unit": "women in the tranexamic acid group",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      },
      {
        "count": 9985,
        "basis": "analyzed",
        "unit": "women in the placebo group",
        "snapshot": "maternal:pmc-pmc5446563-2026-10-11"
      }
    ],
    "arms": [
      {
        "id": "maternal:woman-trial-arm-txa",
        "label": "Tranexamic acid plus usual care",
        "intervention": "maternal:tranexamic-acid-pph-treatment",
        "description": "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."
      },
      {
        "id": "maternal:woman-trial-arm-placebo",
        "label": "Placebo plus usual care",
        "intervention": null,
        "description": "Matching placebo (sodium chloride 0.9%) given the same way in addition to usual care, with the same option of a second dose."
      }
    ],
    "findings": [
      {
        "id": "maternal:f-woman-bleeding-txa",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-death-due-to-bleeding",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_measure": "women who died of bleeding (count)",
        "numeric_value": 155,
        "reported_text": "155 [1·5%] of 10 036",
        "unit": "women",
        "denominator": 10036,
        "denominator_status": null,
        "denominator_basis": "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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-bleeding-placebo",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-placebo",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-death-due-to-bleeding",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_measure": "women who died of bleeding (count)",
        "numeric_value": 191,
        "reported_text": "191 [1·9%] of 9985",
        "unit": "women",
        "denominator": 9985,
        "denominator_status": null,
        "denominator_basis": "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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-bleeding-rr",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": "maternal:woman-trial-arm-placebo",
        "claim_id": "maternal:claim-woman-death-due-to-bleeding",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_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)",
        "numeric_value": 0.81,
        "reported_text": "RR 0·81, 95% CI 0·65–1·00; p=0·045",
        "unit": "ratio",
        "denominator": null,
        "denominator_status": "not_applicable",
        "denominator_basis": "Comparison of the two per-arm rows above",
        "time_window": "From randomisation to death, discharge or 42 days, whichever came first",
        "estimate_lower": 0.65,
        "estimate_upper": 1,
        "interval_method": "95% confidence interval",
        "interval_status": null
      },
      {
        "id": "maternal:f-woman-3h-txa",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-treated-within-3h",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-within-3h",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_measure": "women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)",
        "numeric_value": 89,
        "reported_text": "89 [1·2%]",
        "unit": "women",
        "denominator": null,
        "denominator_status": null,
        "denominator_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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-3h-placebo",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-treated-within-3h",
        "arm_id": "maternal:woman-trial-arm-placebo",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-within-3h",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_measure": "women who died of bleeding after treatment within 3 hours of birth (count, pre-specified subgroup)",
        "numeric_value": 127,
        "reported_text": "127 [1·7%]",
        "unit": "women",
        "denominator": null,
        "denominator_status": null,
        "denominator_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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-3h-rr",
        "outcome_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "context_id": "maternal:ctx-woman-treated-within-3h",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": "maternal:woman-trial-arm-placebo",
        "claim_id": "maternal:claim-woman-within-3h",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "secondary",
        "effect_measure": "risk ratio, tranexamic acid vs placebo, within 3 hours of birth (pre-specified subgroup)",
        "numeric_value": 0.69,
        "reported_text": "RR 0·69, 95% CI 0·52–0·91; p=0·008",
        "unit": "ratio",
        "denominator": null,
        "denominator_status": "not_applicable",
        "denominator_basis": "Comparison of the two per-arm rows above",
        "time_window": "From randomisation to death, discharge or 42 days, whichever came first",
        "estimate_lower": 0.52,
        "estimate_upper": 0.91,
        "interval_method": "95% confidence interval",
        "interval_status": null
      },
      {
        "id": "maternal:f-woman-allcause-txa",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-all-cause-death",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "not_specified",
        "effect_measure": "women who died from any cause (count)",
        "numeric_value": 227,
        "reported_text": "227 [2·3%]",
        "unit": "women",
        "denominator": 10036,
        "denominator_status": null,
        "denominator_basis": "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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-allcause-placebo",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-placebo",
        "comparator_arm_id": null,
        "claim_id": "maternal:claim-woman-all-cause-death",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "not_specified",
        "effect_measure": "women who died from any cause (count)",
        "numeric_value": 256,
        "reported_text": "256 [2·6%]",
        "unit": "women",
        "denominator": 9985,
        "denominator_status": null,
        "denominator_basis": "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",
        "estimate_lower": null,
        "estimate_upper": null,
        "interval_method": null,
        "interval_status": "not_applicable"
      },
      {
        "id": "maternal:f-woman-allcause-rr",
        "outcome_id": "core:outcome-death-any-cause",
        "context_id": "maternal:ctx-woman-women-16plus-clinical-pph",
        "arm_id": "maternal:woman-trial-arm-txa",
        "comparator_arm_id": "maternal:woman-trial-arm-placebo",
        "claim_id": "maternal:claim-woman-all-cause-death",
        "snapshot_id": "maternal:pmc-pmc5446563-2026-10-11",
        "endpoint_role": "not_specified",
        "effect_measure": "risk ratio, tranexamic acid vs placebo, unadjusted",
        "numeric_value": 0.88,
        "reported_text": "RR 0·88, 95% CI 0·74–1·05; p=0·16",
        "unit": "ratio",
        "denominator": null,
        "denominator_status": "not_applicable",
        "denominator_basis": "Comparison of the two per-arm rows above",
        "time_window": "From randomisation to death, discharge or 42 days, whichever came first",
        "estimate_lower": 0.74,
        "estimate_upper": 1.05,
        "interval_method": "95% confidence interval",
        "interval_status": null
      }
    ]
  },
  "content_digest": "db252fae6cff1b61b9b98f9a6defa8c3f6541b516a4d882dc4143bcda34afa84",
  "review": {
    "content_digest": "db252fae6cff1b61b9b98f9a6defa8c3f6541b516a4d882dc4143bcda34afa84",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests tranexamic acid added to usual care",
        "clinical_claim_not_fact": false,
        "other_entity_id": "maternal:tranexamic-acid-pph-treatment",
        "other_entity_in_atlas": true,
        "claim_id": null
      },
      {
        "predicate": "investigates",
        "label": "Enrolled women with a clinical diagnosis of postpartum haemorrhage",
        "clinical_claim_not_fact": false,
        "other_entity_id": "maternal:postpartum-hemorrhage",
        "other_entity_in_atlas": true,
        "claim_id": null
      },
      {
        "predicate": "investigates",
        "label": "Key secondary outcome",
        "clinical_claim_not_fact": false,
        "other_entity_id": "maternal:outcome-maternal-death-due-to-bleeding",
        "other_entity_in_atlas": true,
        "claim_id": null
      },
      {
        "predicate": "investigates",
        "label": "Reports death from any cause",
        "clinical_claim_not_fact": false,
        "other_entity_id": "core:outcome-death-any-cause",
        "other_entity_in_atlas": true,
        "claim_id": null
      },
      {
        "predicate": "funded_by",
        "label": "Funder named in the abstract",
        "clinical_claim_not_fact": false,
        "other_entity_id": "maternal:gates-foundation",
        "other_entity_in_atlas": true,
        "claim_id": null
      },
      {
        "predicate": "results_reported_in",
        "label": "Primary results, Lancet 2017",
        "clinical_claim_not_fact": false,
        "other_entity_id": "maternal:pub-woman-lancet-2017",
        "other_entity_in_atlas": true,
        "claim_id": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/woman-trial/",
  "context_path": "api/v1/context/maternal--woman-trial.md"
}