Klaus 1986.
| Methods | RCT. Purposefully enrolled more women to the control group. See 'Risk of bias' table below | |
| Participants | 465 healthy nulliparous women (186 to support group and 279 to control) in labour at the Social Security Hospital in Guatemala | |
| Interventions | Support group: continuous emotional and physical support by a doula. Control group: usual hospital routines (described as no consistent support) |
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| Outcomes | Labour length, use of artificial oxytocin, method of birth, problems during labour and birth, fetal distress, Apgar scores, transfer to neonatal intensive care nursery | |
| Notes | No family members permitted to be present. epidural analgesia was not available and EFM was not used routinely Dates of study: not clear, accepted by journal June 1986 Funding: grants from the Thraher Fund, the Pitway Corporation Charitable Foundation, and the Maternal and Child Health Research (MC‐R‐390430). 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 | "Enrolled using randomised design". "Pool of envelopes contained more control group to ensure similar sized groups with uncomplicated labours and deliveries." They anticipated more complications in control group based on an earlier study (Sosa 1980). No information on how allocation sequence was generated |
| Allocation concealment (selection bias) | Low risk | "Randomly assigned according to contents of a sealed opaque envelope. Each envelope was numbered sequentially." |
| 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 | Unclear risk | Unclear who assessed the outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "Mother‐infant pairs were excluded when the mother developed a complication during labour, delivery, or post partum that required special care, if the baby's weight was below 5.5 lbs or above 8 lbs, if there were twins or congenital malformations." This occurred for about 10% of cases in both groups resulting in reported outcomes for 89.6% of those randomised. Unpublished data on the excluded women were provided by the author. Labour length data were only available for 48.4% of the sample (225 of 465) and thus not included |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |