{
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  "id": "maternal:premod2-trial",
  "owner": "maternal",
  "kind": "study",
  "slug": "premod2-trial",
  "name": "PREMOD2 trial (cord milking against delayed clamping)",
  "aliases": [],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A trial in babies born at 23 to 31 weeks that compared milking the cord toward the baby with waiting before clamping. It was stopped early because severe bleeding in the brain was more common with cord milking.",
  "summary_technical": "Noninferiority randomised trial reported in JAMA 2019 (ClinicalTrials.gov NCT03019367): 540 infants randomised, 474 enrolled and completed (236 cord milking, 238 delayed clamping), against a plan of 750 per group. A safety signal at the first interim analysis stopped enrolment, so the planned noninferiority analysis could not be done and a post hoc comparison was made. The registry record lists the status as completed and an actual enrolment of 1201; this record keeps the registry figures beside the paper's without reconciling them. The harm signal belongs to cord milking, not to delayed clamping.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
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      "life-stage": [
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      "care-area": [
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  "payload": {
    "design": "Multicentre randomised parallel-group trial at nine university and private medical centres, planned as a noninferiority trial; the registry lists triple masking. Infants born at 23 to 31 weeks were assigned to umbilical cord milking or delayed cord clamping. Enrolment ran from June 2017 to September 2018, with final follow-up in December 2018 (abstract).",
    "drug_phase": "not_applicable",
    "registry_statuses": [
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        "status": "COMPLETED",
        "snapshot": "maternal:ctgov-nct03019367-2026-10-14"
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    "start_date": {
      "date": "2017-06-06",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03019367-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2022-09-16",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03019367-2026-10-14"
    },
    "completion_date": {
      "date": "2022-09-16",
      "type": "actual",
      "snapshot": "maternal:ctgov-nct03019367-2026-10-14"
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    "countries": [
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    "care_setting": {
      "description": "Nine university and private medical centres in four countries.",
      "snapshot": "maternal:pubmed-31742630-2026-10-14"
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    "stopped_early": {
      "scope": "enrollment",
      "date": null,
      "reason": "A safety signal, an imbalance in the number of severe intraventricular haemorrhage events between the groups, was seen at the first interim analysis, and the data and safety monitoring board recommended stopping enrolment. The registry lists the study as completed.",
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      },
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        "basis": "enrolled",
        "unit": "infants (enrolled and completed the trial)",
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    ],
    "arms": [
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        "id": "maternal:premod2-trial-arm-milking",
        "label": "Umbilical cord milking",
        "intervention": null,
        "description": "Umbilical cord milking. 236 infants were in this group."
      },
      {
        "id": "maternal:premod2-trial-arm-delayed",
        "label": "Delayed cord clamping",
        "intervention": "maternal:delayed-cord-clamping",
        "description": "Delayed umbilical cord clamping. 238 infants were in this group."
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      "category": "safety",
      "statement": "In PREMOD2, babies born at 23 to 31 weeks who received umbilical cord milking had more severe intraventricular haemorrhage (bleeding in the brain) than babies who had delayed cord clamping: 8% (20 of 236) against 3% (8 of 238), a risk difference of 5% (95% CI 1% to 9%; P = .02). At 23 to 27 weeks it was 22% (20 of 93) against 6% (5 of 89). Enrolment was stopped early because of this signal. The combined outcome of death or severe haemorrhage was 12% (29 of 236) against 8% (20 of 238), a difference that was not statistically significant. The signal belongs to cord milking; delayed clamping was the comparison group.",
      "context": {
        "id": "maternal:ctx-premod2-preterm-23-31-weeks",
        "label": "Infants born at 23 to 31 weeks of gestation (PREMOD2 trial)",
        "recipient": "newborn",
        "population": "Preterm infants born at 23 to 31 weeks of gestation. 540 infants were randomised and 474 (88%) were enrolled and completed the trial (236 cord milking, 238 delayed clamping). Enrolment stopped early, short of the planned 750 per group.",
        "care_setting": "Nine university and private medical centres.",
        "geography": "Four countries; the abstract does not name them. ClinicalTrials.gov lists the United States, Canada, Germany and Ireland.",
        "life_stage_note": "Preterm infants born at 23 to 31 weeks of gestation",
        "life_stage_terms": {
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        "gestational_age_min_days": 161,
        "gestational_age_max_days": 223,
        "gestational_age_basis": "at_birth",
        "postnatal_age_min_days": null,
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        "followup_description": "Death or severe intraventricular haemorrhage; final follow-up December 2018.",
        "eligibility": {
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          "exclusion": []
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      "evidence_stage": "interventional",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The trial stopped early, so the planned noninferiority analysis could not be done and the reported comparison is post hoc. The authors state that the early stop and the post hoc nature of the analyses preclude definitive conclusions. The subgroup interaction by gestational age was reported for severe haemorrhage only. 474 of 540 randomised infants were enrolled and completed the trial. Only the abstract was read.",
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