Bréart ‐ France 1992.
Methods | See Bréart ‐ Belgium 1992 | |
Participants | See Bréart ‐ Belgium 1992 Trial in France: N = 1320 (656 continuous support; 664 control) | |
Interventions | See Bréart ‐ Belgium 1992. Fathers were allowed to be present | |
Outcomes | See Bréart ‐ Belgium 1992 | |
Notes | Epidural analgesia was available and it is unknown whether EFM was routine Dates of study: not clear, trials ended in 1992 Funding: not clear ‐ "European Community concerted action". Conflicts of interest: Not reported. |
|
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 was > 95%. There were some discrepancies in the total number enrolled. Two reports show 656 in the permanent support group and 664 in the control group for a total of 1320. The table of results in 1 report shows 654 in the permanent support and 666 in control. The in‐hospital questionnaire results are shown for 654 and 664 women (total 1318) but the authors state this is 95% of the sample, meaning the total is 1386. The N reported for each outcome were used in the data tables in this review |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Low risk | No other sources of bias noted |