{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:arrive-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "arrive-trial",
  "name": "ARRIVE trial (induction at 39 weeks in low-risk first births)",
  "aliases": [
    "ARRIVE",
    "A Randomized Trial of Induction Versus Expectant Management"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A large trial in the United States that asked whether offering induction at 39 weeks to healthy first-time mothers leads to better results than waiting for labour to start on its own. About 6100 women took part. Induction did not clearly lower the main outcome, a mix of baby deaths and serious newborn problems, but it did lower the caesarean rate. The registry lists no masking.",
  "summary_technical": "Randomised, parallel-group trial (NCT01990612; phase not applicable). The registry enrolled count is 6106 (actual); the abstract gives 3062 women assigned to induction at 39 weeks 0 days to 39 weeks 4 days and 3044 assigned to expectant management, women randomised at 38 weeks 0 days to 38 weeks 6 days. Primary outcome: a composite of perinatal death or severe neonatal complications. Principal secondary outcome: caesarean delivery. The registry induction arm used oxytocin, with cervical ripening first (method left to the physician) when the cervix was unfavourable. Registry lead sponsor: The George Washington University Biostatistics Center (no organisation record in this atlas), with NICHD as collaborator; the abstract says the trial was funded by NICHD. The funded_by link to NICHD rests on the abstract's funding statement, not on the registry collaborator line. The registry start date has no type; results were first posted 2019-01-25 and were not read.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT01990612",
      "normalized_value": "NCT01990612",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "pregnancy",
        "childbirth"
      ],
      "care-area": [
        "labour-and-birth"
      ]
    }
  },
  "payload": {
    "design": "Allocation: randomised. Intervention model: parallel. Masking: none listed. Primary purpose: prevention. Women were randomly assigned to induction of labour at 39 weeks 0 days to 39 weeks 4 days or to expectant management (registry values, paraphrased).",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2014-03",
      "type": null,
      "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2017-11",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
    },
    "completion_date": {
      "date": "2018-01",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
    },
    "results_first_posted": {
      "date": "2019-01-25",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
      }
    ],
    "care_setting": {
      "description": "Multicentre trial in the United States. The abstract does not say what kind of site took part.",
      "snapshot": "maternal:pubmed-30089070-2026-10-14"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 6106,
        "basis": "enrolled",
        "unit": "women (registry enrollment, type ACTUAL)",
        "snapshot": "maternal:ctgov-nct01990612-2026-10-14"
      },
      {
        "count": 3062,
        "basis": "randomized",
        "unit": "women assigned to labour induction",
        "snapshot": "maternal:pubmed-30089070-2026-10-14"
      },
      {
        "count": 3044,
        "basis": "randomized",
        "unit": "women assigned to expectant management",
        "snapshot": "maternal:pubmed-30089070-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:arrive-trial-arm-induction",
        "label": "Elective induction of labour at 39 weeks 0 days to 39 weeks 4 days",
        "intervention": "maternal:induction-of-labour",
        "description": "Induction of labour between 39 weeks 0 days and 39 weeks 4 days in women with no medical indication; the registry says induction was by oxytocin, after cervical ripening when the cervix was unfavourable."
      },
      {
        "id": "maternal:arrive-trial-arm-expectant",
        "label": "Expectant management",
        "intervention": null,
        "description": "Expectant management, unless a medical indication arose, until at least 40 weeks 5 days (registry arm description)."
      }
    ],
    "findings": []
  },
  "content_digest": "91a8b9eca967e437cb687bc892fe3a8cd68f30157889eed43d0ffb5b924a5e7e",
  "review": {
    "content_digest": "91a8b9eca967e437cb687bc892fe3a8cd68f30157889eed43d0ffb5b924a5e7e",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests induction at 39 weeks against expectant management",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:induction-of-labour",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct01990612-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "funded_by",
        "label": "The abstract states the trial was funded by NICHD",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:nichd",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-30089070-2026-10-14",
          "locator": "Abstract, CONCLUSIONS, sentence 2"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/arrive-trial/",
  "context_path": "api/v1/context/maternal--arrive-trial.md"
}
