{
  "release_id": "fc5a600ec7387e71",
  "id": "maternal:mfmu-mild-gdm-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "mfmu-mild-gdm-trial",
  "name": "MFMU trial of treatment for mild gestational diabetes",
  "aliases": [
    "MFMU mild GDM trial",
    "Gestational Diabetes Mellitus Trial (GDM)"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A US randomized trial in women with mild gestational diabetes. Women were assigned to usual prenatal care or to diet advice, home blood sugar checks and insulin if needed. Treatment did not significantly reduce the main combined outcome for babies, but several other outcomes, such as large babies, caesarean births and high blood pressure disorders of pregnancy, were less common with treatment.",
  "summary_technical": "Randomized, parallel trial; the registry lists no masking. Registered as NCT00069576 (phase not applicable); lead sponsor The George Washington University Biostatistics Center (no organization record in this atlas, so no sponsor link is written), collaborator NICHD. The funded_by link to NICHD rests on the grants that the paper's PubMed record lists, not on the registry collaborator line. The abstract reports 958 women randomly assigned (485 treatment, 473 control); the registry reports an actual enrollment of 7381. The two counts are different, the registry gives no unit, and the atlas does not reconcile them. Results are recorded as separate claims on this page; the primary result (P=0.14) was not significant. The registry also lists a follow-up of children at 5 to 10 years as a primary outcome; it is not recorded here.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT00069576",
      "normalized_value": "NCT00069576",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
        "pregnancy",
        "newborn"
      ],
      "care-area": [
        "pregnancy-conditions"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group trial of treatment (dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary) against usual prenatal care in women with mild gestational diabetes, in the 24th to 31st week of gestation.",
    "drug_phase": "not_applicable",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2002-10",
      "type": null,
      "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2007-11",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
    },
    "completion_date": {
      "date": "2013-10",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
    },
    "results_first_posted": {
      "date": "2019-05-31",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 7381,
        "basis": "enrolled",
        "unit": "participants (registry enrollment, type ACTUAL; the registry gives no unit)",
        "snapshot": "maternal:ctgov-nct00069576-2026-10-14"
      },
      {
        "count": 958,
        "basis": "randomized",
        "unit": "women",
        "snapshot": "maternal:pubmed-19797280-2026-10-14"
      },
      {
        "count": 485,
        "basis": "randomized",
        "unit": "women assigned to treatment",
        "snapshot": "maternal:pubmed-19797280-2026-10-14"
      },
      {
        "count": 473,
        "basis": "randomized",
        "unit": "women assigned to the control group",
        "snapshot": "maternal:pubmed-19797280-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "maternal:mfmu-mild-gdm-trial-arm-treatment",
        "label": "Treatment",
        "intervention": "maternal:gdm-treatment",
        "description": "Dietary intervention, self-monitoring of blood glucose, and insulin therapy if necessary. The registry labels the arm Nutritional counseling and self blood glucose monitoring."
      },
      {
        "id": "maternal:mfmu-mild-gdm-trial-arm-control",
        "label": "Control (usual prenatal care)",
        "intervention": null,
        "description": "Usual prenatal care. The registry labels the arm No treatment and says the group received written information on general nutrition for normal pregnancy."
      }
    ],
    "findings": []
  },
  "content_digest": "2b7b23d963e9fbae89b15fa2350041417052c2e66158c90095f657526160a672",
  "review": {
    "content_digest": "2b7b23d963e9fbae89b15fa2350041417052c2e66158c90095f657526160a672",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests treatment of mild gestational diabetes against usual prenatal care",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:gdm-treatment",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:pubmed-19797280-2026-10-14",
          "locator": "Abstract, METHODS, sentence 1, fragment 3 of 3"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Registry condition: Diabetes, Gestational",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "maternal:gestational-diabetes",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "maternal:ctgov-nct00069576-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "funded_by",
        "label": "The PubMed record lists NICHD grants for the paper",
        "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-19797280-2026-10-14",
          "locator": "PubmedArticle, GrantList, Grant 1, Agency"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/mfmu-mild-gdm-trial/",
  "context_path": "api/v1/context/maternal--mfmu-mild-gdm-trial.md"
}