Hofmeyr 1991.
| Methods | RCT | |
| Participants | 189 nulliparous women (92 to support and 97 to control) in active labour at a community hospital serving low‐income women in South Africa | |
| Interventions | Intervention group: support by carefully trained, volunteer lay women, for at least several hours (supporters not expected to remain after dark). Control group: intermittent care on a busy ward. Spouses/family members were not permitted |
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| Outcomes | Intrapartum interventions, method of birth, complications (mother and baby), anxiety, pain, mothers' perceptions of labour, breastfeeding | |
| Notes | Epidural analgesia was not available and EFM was not used routinely. While scores on an instrument measuring postpartum depression were reported in categories of "low", "moderate," and 'high", the authors stated that categorisation was not appropriate as a clinical diagnostic definition of depression. To achieve the latter, the change in score must be reported, and these data were not collected Dates of study: not clear, received by journal 1990 Funding: South African Medical Research Council. Conflicts of interest: not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random |
| Allocation concealment (selection bias) | Unclear risk | "Randomly ordered cards in sealed opaque envelopes". Not stated if consecutively numbered |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | It was not possible to keep the interviewer blind to the group assignment, as sometimes participants volunteered information which identified them as belonging to 1 group or another |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were collected on 100% of the sample and questionnaires within 24 hours postpartum were completed by 99%. The 6‐week follow‐up interviews were completed by 78.8% of the sample, no imbalances existed between groups and thus the data were included in the analysis. At 1‐year interviews were complete for 46% of the sample and data from these were not used. Nikodem reported on a larger sample of women with 1‐year follow‐ups but the completion rate was still only 50% of the original number enrolled |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |