{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:woman-2-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "woman-2-trial",
  "name": "WOMAN-2 trial (tranexamic acid in women with anaemia)",
  "aliases": [
    "WOMAN-2",
    "World Maternal Antifibrinolytic Trial_2"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "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.",
  "summary_technical": "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).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT03475342",
      "normalized_value": "NCT03475342",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    },
    {
      "scheme": "isrctn",
      "value": "ISRCTN62396133",
      "normalized_value": "ISRCTN62396133",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    },
    {
      "scheme": "pactr",
      "value": "PACTR201909735842379",
      "normalized_value": "PACTR201909735842379",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "childbirth",
        "postpartum"
      ],
      "care-area": [
        "postpartum-recovery"
      ]
    }
  },
  "payload": {
    "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.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2019-08-24",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2023-09-20",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
    },
    "completion_date": {
      "date": "2023-10-29",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
    },
    "results_first_posted": null,
    "countries": [
      {
        "code": "NG",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      },
      {
        "code": "PK",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      },
      {
        "code": "TZ",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      },
      {
        "code": "ZM",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "34 hospitals across four countries (Nigeria, Pakistan, Tanzania and Zambia).",
      "snapshot": "maternal:pubmed-39461792-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 15068,
        "basis": "enrolled",
        "unit": "women (registry enrollment, type ACTUAL)",
        "snapshot": "maternal:ctgov-nct03475342-2026-10-14"
      },
      {
        "count": 7580,
        "basis": "randomized",
        "unit": "women assigned to tranexamic acid",
        "snapshot": "maternal:pubmed-39461792-2026-10-14"
      },
      {
        "count": 7488,
        "basis": "randomized",
        "unit": "women assigned to placebo",
        "snapshot": "maternal:pubmed-39461792-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:woman-2-trial-arm-txa",
        "label": "Tranexamic acid 1 g",
        "intervention": "maternal:tranexamic-acid-pph-prevention",
        "description": "1 g of tranexamic acid by slow intravenous injection over 10 minutes within 15 minutes of the umbilical cord being cut or clamped."
      },
      {
        "id": "maternal:woman-2-trial-arm-placebo",
        "label": "Matching placebo",
        "intervention": null,
        "description": "Matching placebo given in the same way."
      }
    ],
    "findings": []
  },
  "content_digest": "f19e7be50dfacddd32af0805402bf18fa901f8f85119d15836edfa47926f5ad6",
  "review": {
    "content_digest": "f19e7be50dfacddd32af0805402bf18fa901f8f85119d15836edfa47926f5ad6",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests tranexamic acid to prevent postpartum haemorrhage",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:tranexamic-acid-pph-prevention",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-39461792-2026-10-14",
          "locator": "Abstract, BACKGROUND, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "The substance tested",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:tranexamic-acid",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct03475342-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "funded_by",
        "label": "Funder named in the abstract",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:gates-foundation",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-39461792-2026-10-14",
          "locator": "Abstract, FUNDING, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/woman-2-trial/",
  "context_path": "api/v1/context/maternal--woman-2-trial.md"
}