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. 2020 Jul 15;2020(7):CD004945. doi: 10.1002/14651858.CD004945.pub5

Cole 1975.

Study characteristics
Methods Randomly allocated, no further details available
Participants Number of women randomised: 228
Setting: Glasgow, Scotland
Study date: not reported
Inclusion criteria
  • Primigravidae aged 18‐30 years

  • 1‐3 parity, aged 18‐35 years who had previous pregnancies without any obstetric abnormality

  • Certain date of LMP

  • Regular menstrual cycle

  • Early examination which had shown the uterine size to be consistent with the period of amenorrhoea

  • GA: 39‐40 weeks


State of cervix: not reported
Interventions Induction group (n = 111): IOL with AROM + oxytocin
versus
EM group (n = 117): no intervention until 41 weeks, thereafter IOL
Outcomes Mother: length of labour; mode of birth (including operative versus non operative); analgesia requirements; postpartum blood loss
Baby: perinatal deaths; meconium staining; Apgar scores; birthweight; neonatal jaundice
Notes Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of sequence generation was not reported.
Allocation concealment (selection bias) Unclear risk The method of allocation concealment was not reported.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding was not feasible.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Blinded outcome assessment was not mentioned.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 7/118 and 2/119 in the intervention and control groups excluded after randomisation because of misclassification as low risk
Selective reporting (reporting bias) Unclear risk No outcomes were prespecified in the methods; no access to trial protocol to further assess selective reporting
Other bias Low risk Appeared to be free of other bias