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) |
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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 |
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Outcomes | Mother: duration of labour; mode of birth Baby: morbidity (Apgar scores, resuscitation) | |
Notes |
Funding: not reported Declaration of interests: not reported |
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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 |