{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:champion-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "champion-trial",
  "name": "CHAMPION trial (heat-stable carbetocin against oxytocin)",
  "aliases": [
    "CHAMPION"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A large trial in 10 countries that compared a heat-stable form of carbetocin with oxytocin, each given by injection right after a vaginal birth, to prevent heavy bleeding. Heat-stable carbetocin was no worse than oxytocin for the first main outcome, blood loss of 500 mL or more or extra medicine to stop bleeding. For the second main outcome, blood loss of 1000 mL or more, noninferiority was not shown, and the authors say the low event rates reduced the power of the trial.",
  "summary_technical": "Randomised, double-blind, noninferiority trial (2018; PMID 29949473) at 23 sites in 10 countries; 29,645 women underwent randomisation. Registry numbers named in the PubMed record: ACTRN12614000870651 (ANZCTR), EudraCT 2014-004445-26 and CTRI/2016/05/006969; the registry records were not fetched, so no registry dates or status are recorded. Funded by Merck Sharpe & Dohme, as the abstract spells the name. The 2025 postpartum haemorrhage guideline calls it a multi-country trial of nearly 30 000 women. Both drugs were kept in cold storage to maintain double-blinding.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "anzctr",
      "value": "ACTRN12614000870651",
      "normalized_value": "ACTRN12614000870651",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    },
    {
      "scheme": "eudract",
      "value": "2014-004445-26",
      "normalized_value": "2014-004445-26",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    },
    {
      "scheme": "ctri",
      "value": "CTRI/2016/05/006969",
      "normalized_value": "CTRI/2016/05/006969",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "childbirth",
        "postpartum"
      ],
      "care-area": [
        "postpartum-recovery"
      ]
    }
  },
  "payload": {
    "design": "Randomised, double-blind, noninferiority trial comparing intramuscular heat-stable carbetocin 100 micrograms with intramuscular oxytocin 10 IU, given immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8 degrees Celsius) to maintain double-blinding.",
    "drug_phase": null,
    "registry_statuses": [],
    "start_date": null,
    "primary_completion_date": null,
    "completion_date": null,
    "results_first_posted": null,
    "countries": [
      {
        "code": "AR",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "EG",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "KE",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "NG",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "SG",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "UG",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "maternal:champion-anzctr-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "23 sites in 10 countries. The abstract does not say what kind of site took part or name the countries.",
      "snapshot": "maternal:pubmed-29949473-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 29645,
        "basis": "randomized",
        "unit": "women",
        "snapshot": "maternal:pubmed-29949473-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:champion-trial-arm-carbetocin",
        "label": "Heat-stable carbetocin 100 micrograms intramuscularly",
        "intervention": "maternal:carbetocin",
        "description": "Heat-stable carbetocin 100 micrograms by intramuscular injection immediately after vaginal birth."
      },
      {
        "id": "maternal:champion-trial-arm-oxytocin",
        "label": "Oxytocin 10 IU intramuscularly",
        "intervention": "maternal:uterotonic-pph-prevention",
        "description": "Oxytocin 10 IU by intramuscular injection immediately after vaginal birth (the usual uterotonic for preventing bleeding)."
      }
    ],
    "findings": []
  },
  "content_digest": "59ffc83740a86793eec9a6e45e404da7fd8dabcd4431fa64dee317a1a50daec2",
  "review": {
    "content_digest": "59ffc83740a86793eec9a6e45e404da7fd8dabcd4431fa64dee317a1a50daec2",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests heat-stable carbetocin against oxytocin",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:carbetocin",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-29949473-2026-10-14",
          "locator": "Abstract, BACKGROUND, sentence 3, and METHODS, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Comparator: oxytocin 10 IU",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:oxytocin",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-29949473-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1, fragment 2 of 3"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Compares two uterotonics for preventing postpartum haemorrhage",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:uterotonic-pph-prevention",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-29949473-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 1"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/champion-trial/",
  "context_path": "api/v1/context/maternal--champion-trial.md"
}