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. 2019 Sep 17;2019(9):CD003248. doi: 10.1002/14651858.CD003248.pub4

McDonnell 1997.

Methods Randomised controlled trial, stratified by vaginal or CS, 26 to 29 weeks, 30 to 33 weeks.
Participants Inclusion criteria
  • Infants at 26 to 33 weeks' gestation

  • Vaginal or CS

  • Single or multiple pregnancies. 4 sets of twins included with each twin randomised separately.

  • N = 46 babies


Exclusion criteria
  • Severe fetal distress, IUGR with abnormal umbilical Doppler waveforms, fetal hydrops, fetal malformations, Rhesus incompatibility.

Interventions Intervention: DCC
  • Cord clamped at 30 secs, infant positioned between legs of the mother

  • Syntocinon at birth of the infant

  • N = 23 babies


Comparator: ECC
  • Cord clamped immediately

  • N = 23 babies


Additional information
  • Gestational subgroup: < 32‐34 weeks' gestation

  • Resuscitation with cord intact: not available

  • Access to NICU: yes

  • Length of delay: 30 secs

  • Baby placed: between mother's legs

  • Uterotonic: syntocinon given IV after birth of infant according to standard practice

  • UCM: n/a


Comparison 1
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by gestation)
Subgroup 1: < 32‐34 weeks' gestation
Comparison 2
DCC with neonatal resuscitation after cord clamping vs ECC (subgroup by type intervention)
Subgroup 1: DCC at < 1 min with baby level with uterus and placenta
Outcomes Primary outcome: Hct at 4 hrs.
 Secondary outcomes: Apgar score, temperature on admission, requirement for ventilation, oxygen, surfactant, peak serum bilirubin, inotropic support, cerebral ultrasound, blood transfusion, death
Notes Setting: Sydney, Australia
Dates: January to December 1994
Declaration of interest: not reported
Trial funding source: not reported
Further information
  • Unit of randomisation was the infant ‐ so for twin pregnancies each infant was randomised separately

  • M McDonnell kindly provided additional information regarding this study

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence not stated. There was stratification by gestational age and type of delivery.
Allocation concealment (selection bias) Unclear risk Quote: “sealed opaque envelopes”. Not clear if envelopes numbered and used sequentially.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not mentioned. It is possible that lack of blinding could influence other aspects of care and the recording of outcomes.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding was not mentioned. It is possible that lack of blinding could influence other aspects of care and the recording of outcomes.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 46 infants were randomised. It was not clear in the publication how many infants were in each randomised group and we understand that personal communication with the authors provided the information and data. For the outcomes, of IVH and PVL there were only 31/46 (67%) of data available though death is reported on all babies. Analysis was according to randomisation group.                                              
Selective reporting (reporting bias) Unclear risk Assessment of risk of bias from published trial report. Several outcomes were not reported in the brief trial report although the authors offer other data on request. We did not assess the trial protocol.
Other bias Unclear risk Groups appeared similar at baseline although there were more boys in the immediate clamping group (15 vs 9, denominators not clear).