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

Breart 1982.

Study characteristics
Methods RCT (1:2 randomisation)
Participants Number of women randomised: 716
Setting: Paris, France
Study conducted: not reported
Inclusion criteria: GA: 37‐39 weeks (259‐273 days)
Exclusion criteria: high risk, contraindication for IOL
State of cervix: not mentioned
Parity: mixed (60% nulliparous)
Interventions Induction group (n = 235): oxytocin and AROM at GA 37‐39 weeks
versus
EM group (n = 481): FHR checking and amnioscopy every 2‐3 days
Outcomes Mother: duration of labour; mode of birth
Baby: morbidity (Apgar scores, resuscitation)
Notes Funding: not reported
Declaration of interests: 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 It was reported that a closed envelope system was used for allocation concealment, although no further detail was available.
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 Low risk 202/235 in the induction group and 173/481 in the expectant group followed the trial protocol; trial results were reported for all 716 women and their babies.
Selective reporting (reporting bias) Unclear risk No access to trial protocol to confidently assess selective reporting. Perinatal death was not reported.
Other bias Low risk Appeared to be free of other bias