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. 2013 Sep 12;2013(9):CD000078. doi: 10.1002/14651858.CD000078.pub3

Wallace 1984.

Methods Randomised trial; method not stated.
Participants Inclusion: established preterm labour in cephalic presentation between 26‐33 weeks; single pregnancy; no contraindication to caesarean or vaginal delivery; no congenital anomalies.
 Setting (period of recruitment): Los Angeles County/University of Southern California Medical Center (1981).
 Number of randomised participants: elective 23, selective 15.
Interventions I: vaginal delivery vs II: caesarean delivery.
Outcomes

  • Major maternal postpartum complications

  • Birth injury to infant

  • Birth asphyxia I: 2/9, II: 1/5

  • Mode of birth

  • Neonatal death I: 1/9, II: 1/5

  • Neonatal admission to NICU

  • Postpartum haemorrhage

  • Hypoxic ischaemic encephalopathy I: 2/9, II: 1/5

  • Breastfeeding at discharge

  • Breastfeeding at 3 months

  • Cord pH below normal range

  • Abnormal follow‐up in childhood

  • Neonatal fitting

  • Meconium aspiration

  • Apgar score at 5 min

  • Maternal satisfaction
Notes Trial terminated after 6 months because the proportion (63%) of babies with birthweight > 1500 g was "unacceptably high".
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Details of random sequence generation not reported.
Allocation concealment (selection bias) Unclear risk Details of allocation concealment not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information reported for definitive evaluation of outcome assessment.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 2 women excluded for malpresentation after randomisation. Vaginal delivery group includes 3 randomised to caesarean section who delivered vaginally prior to surgery. 
Selective reporting (reporting bias) Unclear risk Data for 14 cases eligible for the < 1500 g group reported separately.
Other bias Unclear risk High frequency of infants with weight > 1500 g. 38 women participated in total of which only 14 were eligible for the <1500 g group. After enrolling 40 women study discontinued.  Trialists had planned to enrol 175 in each group.