# PREMOD2 trial (cord milking against delayed clamping) Study · id `maternal:premod2-trial` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Childbirth; Newborn Browse, care area: Preterm and sick newborns ## In plain language 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. ## Technical summary 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. ## Key facts - 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). - Phase: Not applicable - Enrolled: 1201 participants (ClinicalTrials.gov gives no unit for the count) (enrolled count; Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2, snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14); 540 infants (randomized count; Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants, snapshot `maternal:pubmed-31742630-2026-10-14`, retrieved 2026-10-14); 474 infants (enrolled and completed the trial) (enrolled count; Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants, snapshot `maternal:pubmed-31742630-2026-10-14`, retrieved 2026-10-14) - Started: 2017-06-06 (actual) (Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2, snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14) - Primary completion: 2022-09-16 (actual) (Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2, snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14) - Completion: 2022-09-16 (actual) (Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2, snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14) - Countries: Canada; Germany; Ireland; United States (Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2, snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14) - Care setting: Nine university and private medical centres in four countries. (Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants, snapshot `maternal:pubmed-31742630-2026-10-14`, retrieved 2026-10-14) - Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct03019367-2026-10-14`, retrieved 2026-10-14) - Stopped early: Enrollment stopped early, date not reported. 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. (Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants, snapshot `maternal:pubmed-31742630-2026-10-14`, retrieved 2026-10-14) ## Claims, with the population each applies to ## Context: 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: Preterm infants born at 23 to 31 weeks of gestation; Gestational age: 23 weeks 0 days (161 days) to 31 weeks 6 days (223 days), measured at birth; Postnatal age: Not reported; Follow-up: Death or severe intraventricular haemorrhage; final follow-up December 2018. ### 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. - Category: Safety - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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: Preterm infants born at 23 to 31 weeks of gestation; Gestational age: 23 weeks 0 days (161 days) to 31 weeks 6 days (223 days), measured at birth; Postnatal age: Not reported; Follow-up: Death or severe intraventricular haemorrhage; final follow-up December 2018. - 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. - Last checked: Not recorded - Sources: 1. Supports: Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, RESULTS, sentences 2 to 4. Retrieved 2026-10-14T18:23:59Z. Source state: Current. Snapshot hash: e5152bcbf3053fc59c8c97bca2f0878f9bd691a61d3c7d0ded773352b17efe07. How it applies: Death or haemorrhage, severe haemorrhage and the 23 to 27 week subgroup. 2. Supports: Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, DESIGN, SETTING, AND PARTICIPANTS, sentences 3 to 4. Retrieved 2026-10-14T18:23:59Z. Source state: Current. Snapshot hash: e5152bcbf3053fc59c8c97bca2f0878f9bd691a61d3c7d0ded773352b17efe07. How it applies: The safety signal that stopped enrolment. 3. Background: Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, INTERVENTIONS and RESULTS sentence 1. Retrieved 2026-10-14T18:23:59Z. Source state: Current. Snapshot hash: e5152bcbf3053fc59c8c97bca2f0878f9bd691a61d3c7d0ded773352b17efe07. How it applies: Group sizes. 4. Background: Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) Locator: Abstract, CONCLUSIONS AND RELEVANCE. Retrieved 2026-10-14T18:23:59Z. Source state: Current. Snapshot hash: e5152bcbf3053fc59c8c97bca2f0878f9bd691a61d3c7d0ded773352b17efe07. How it applies: The authors' own limits on the finding. ## Connected pages - Compares cord milking with delayed clamping: Delayed umbilical cord clamping (`maternal:delayed-cord-clamping`) ## Provenance Content hash: cf5e3c0a19ba02bb6fc701b9ca6a888dcf25c7bbb3261d5a7d03d7a6d45697fa Last substantive edit: 2026-10-14 Evidence last checked: Not recorded