Bréart ‐ Belgium 1992.
Methods | RCT | |
Participants | 3 trials are reported separately in 1 publication. Participants were nulliparous, healthy, in spontaneous labour, term, with singleton vertex presentations. Trial in Belgium: N = 264 (133 permanent support; 131 control) | |
Interventions | Permanent presence of a midwife compared to varying degrees of presence. Fathers were allowed to be present | |
Outcomes | Oxytocin, epidural analgesia, labour length, mode of birth, Apgar scores, mothers' views of their experiences | |
Notes | Epidural analgesia was available and it is not known whether EFM was used routinely Dates of study: not clear, trials ended in 1992 Funding: not clear ‐ "European Community concerted action". Conflicts of interest: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Women were 'randomly assigned'. The envelopes were prepared by the co‐ordinating centre. No mention of the process of sequence generation |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes. No mention if they were opaque or consecutively numbered. The process of how the envelopes were opened was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information provided about blinding of participants or personnel, but blinding of participants and personnel is not possible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided about blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Completion rate for medical record data and in‐hospital questionnaire were 99.2% and 91.0% respectively |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Low risk | No other sources of bias noted |