Cogan 1988.
| Methods | RCT | |
| Participants | 34 women (primigravidas and multigravidas) at 26 to 37 weeks' gestation in 2 Texas hospitals (20 to supported group and 14 to usual care). They were in early, uncomplicated preterm labour | |
| Interventions | Intervention: support provided by a Lamaze childbirth preparation instructor. Support included continuous presence, acting as a liaison with hospital staff, providing information, and teaching relaxation and breathing measures. Usual care: intermittent nursing care. Family members allowed to be present |
|
| Outcomes | Fetal distress, caesarean birth, artificial oxytocin, labour length, Apgar scores, neonatal intensive care | |
| Notes | Not stated if epidural analgesia was available or if EFM was used routinely Dates of study: accepted to journal 1987. Exact dates not reported Funding: not reported. 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 assigned." No further details provided |
| Allocation concealment (selection bias) | Unclear risk | Admitting nurse telephoned research assistant to obtain treatment allocation. No details about whether the research assistant had foreknowledge of the treatment allocation scheme |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, participant's family members and labour room staff were not blinded to group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Medical record information collected by 'research assistants who did not know the group membership of the women'. However, medical records written by staff who were not blinded to group assignment |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Withdrawals occurred before analysis (6 (30%) in support group and 3 (21%) in control). This resulted in a follow‐up rate of 73.5%. The withdrawals were done differentially in the support group, i.e. some women were withdrawn because of an event that occurred before the support person arrived. Women in the control group with the same event were not withdrawn. We were able to re‐create the original study groups for 1 outcome only, caesarean birth, and therefore it was included in the analysis table |
| Selective reporting (reporting bias) | Unclear risk | No outcomes were stated a priori |
| Other bias | Low risk | No other sources of bias noted |