Methods | See Breart - Belgium. | |
Participants | See Breart - Belgium. Trial in France: n = 1320 (656 continuous support; 664 control) |
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Interventions | See Breart - Belgium. Fathers were allowed to be present. | |
Outcomes | See Breart - Belgium. | |
Notes | Epidural analgesia was available and it is unknown whether EFM was routine | |
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 (performance bias and detection bias) All outcomes |
Unclear risk | No details given. |
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. 2 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 with each outcome was the one 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. |