{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:e-motive-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "e-motive-trial",
  "name": "E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)",
  "aliases": [
    "E-MOTIVE",
    "Early Detection of Postpartum Haemorrhage and Treatment Using the World Health Organisation MOTIVE First Response Bundle"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A large trial in 80 hospitals in four African countries that tested a package for heavy bleeding after vaginal birth: a blood-collection drape to measure bleeding early, a bundle of first treatments given together when bleeding passes a set point, and training to make staff use them. Fewer women in the package hospitals had the combined outcome of severe bleeding, surgery for bleeding or death from bleeding (1.6% against 4.3%) than in hospitals giving usual care. The trial tested the whole package, not one part.",
  "summary_technical": "International cluster-randomised trial (2023; PMID 37158447; NCT04341662). 80 secondary-level hospitals in Kenya, Nigeria, South Africa and Tanzania, 210,132 patients who underwent vaginal delivery, randomised by hospital to the intervention or to usual care. The intervention was a calibrated blood-collection drape for early detection, a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation) and an implementation strategy. The primary composite outcome and the results are on the existing claim for the bundle (claim-emotive-detection); no finding is repeated here. Registry: lead sponsor University of Birmingham (no organisation record in this atlas yet); enrolment 99,659 (actual), a different basis from the paper, with research participants described as health care providers attending vaginal births; the registry also lists Pakistan, which the paper does not name among its four countries; the study record lists all five, each with the snapshot that names it, and the two sources are not reconciled. The abstract says the trial was funded by the Bill and Melinda Gates Foundation.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT04341662",
      "normalized_value": "NCT04341662",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "childbirth",
        "postpartum"
      ],
      "care-area": [
        "postpartum-recovery"
      ]
    }
  },
  "payload": {
    "design": "International cluster-randomised trial; the hospital was the unit of randomisation. Registry values: allocation randomised, parallel model, no masking listed.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2020-10-13",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2023-03-24",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
    },
    "completion_date": {
      "date": "2023-03-24",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
    },
    "results_first_posted": {
      "date": "2024-08-06",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
    },
    "countries": [
      {
        "code": "KE",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      },
      {
        "code": "NG",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      },
      {
        "code": "ZA",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      },
      {
        "code": "TZ",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      },
      {
        "code": "PK",
        "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 99659,
        "basis": "enrolled",
        "unit": "participants (registry enrollment, type ACTUAL; the registry describes participants as health care providers attending vaginal births)",
        "snapshot": "maternal:ctgov-nct04341662-2026-10-14"
      },
      {
        "count": 80,
        "basis": "randomized",
        "unit": "hospitals (secondary-level hospitals randomised as clusters)",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      },
      {
        "count": 210132,
        "basis": "unknown",
        "unit": "patients who underwent vaginal delivery in the randomised hospitals (the hospitals, not the patients, were randomised)",
        "snapshot": "maternal:pubmed-37158447-2026-10-11"
      }
    ],
    "arms": [
      {
        "id": "maternal:e-motive-trial-arm-bundle",
        "label": "E-MOTIVE intervention",
        "intervention": "maternal:pph-detection-and-first-response-bundle",
        "description": "Early detection of postpartum haemorrhage with a calibrated drape, a first-response bundle called MOTIVE (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination and escalation) and an implementation strategy."
      },
      {
        "id": "maternal:e-motive-trial-arm-usual",
        "label": "Usual care",
        "intervention": null,
        "description": "Usual care with dissemination of the current guidelines (registry arm description)."
      }
    ],
    "findings": []
  },
  "content_digest": "7b2a6da37f98700d6f4b56369bd38f246daad299289f37e2046ca414bb656295",
  "review": {
    "content_digest": "7b2a6da37f98700d6f4b56369bd38f246daad299289f37e2046ca414bb656295",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests the early detection and first-response bundle",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:pph-detection-and-first-response-bundle",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-37158447-2026-10-11",
          "locator": "Abstract, METHODS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tests a calibrated blood-collection drape as part of the package",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:calibrated-blood-collection-drape",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-37158447-2026-10-11",
          "locator": "Abstract, METHODS, sentence 2"
        },
        "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-37158447-2026-10-11",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Tranexamic acid is one part of the MOTIVE first-response bundle that the trial tests; the trial does not test it alone",
        "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-nct04341662-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].description"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/e-motive-trial/",
  "context_path": "api/v1/context/maternal--e-motive-trial.md"
}