Madi 1999.
| Methods | RCT | |
| Participants | 109 Black women from Botswana (53 in support group and 56 in usual care group), mean age 19 years, 80% unmarried, mostly students, who had met the following criteria: nulliparous, in labour, pregnancy at term, no history of pregnancy complications, cephalic presentation, normal spontaneous labour with cervical dilation 1 to 6 cm, female relative present who was willing to remain with the woman for the duration of labour | |
| Interventions | Support group: continuous presence of female relative (usually her mother) in addition to usual hospital care. Congrol group: usual hospital care, which involved staff:patient ratios of 1:4, and no companions permitted during labour |
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| Outcomes | Spontaneous vaginal birth, vacuum extraction, caesarean birth, analgesia, amniotomy, artificial oxytocin during labour, Apgar scores (1‐ and 5‐min) | |
| Notes | Epidural analgesia was not available and it was not stated whether EFM was used routinely Dates of study: October 1994 ‐ January 1995 Funding: part of Master's degree of Banyana Cecilia Madi, sponsored by Government of Botswana. 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 | "Randomly allocated." No other details provided |
| Allocation concealment (selection bias) | Low risk | "Selection of an opaque, numbered, sealed envelope from a box of envelopes that were shuffled in the woman's presence. When opened the envelope revealed a code indicating her group." An assistant that was not involved in the recruitment process shuffled the envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participants' families, and labour room staff were not blinded to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | The researcher, who was involved in the recruitment of participants, collected the medical record data |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were collected on 100% of the sample |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |