Bruggemann 2007.
| Methods | RCT | |
| Participants | 212 nulliparous women in active labour at term (105 support group, 107 control group) at a University‐affiliated hospital in São Paulo, Brazil. To be eligible a companion of the woman's choosing had to be available. 49.5% of the companions were present at enrolment and the others were phoned and asked to come to the hospital (4 failed to make it before delivery) | |
| Interventions | Support was 'presence of a chosen companion during labour and delivery'. 'The companions received verbal and written information on the activities involved in providing support, expected behaviour when confronted with signs of tiredness, anxiety, concern, crying, screaming and/or the woman's feelings of inability to cope, compliance with regulations and the possibility of requesting information from staff'. in 47.6% of the sample the woman's companion was her partner, for 29.5% it was her mother. The control group received usual care where a companion during labour and delivery was not permitted. For both groups labour and delivery care was provided 'according to the routine protocol including active management of labour (early amniotomy, use of oxytocin, intermittent EFM and systematic analgesia)' |
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| Outcomes | Satisfaction with labour and delivery, perinatal and breastfeeding outcome in the 12 hours post delivery | |
| Notes | All women in labour at this hospital received epidural analgesia as a routine practice. Therefore, we did not include epidural analgesia data in the review. EFM was not used routinely Dates of study: February 2004 ‐ March 2005 Funding: financial support of CAPES (Coordination of improvement for graduated personnel), Brazil. Conflicts of interest: The author(s) declare that they have no competing interests. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | 'Computer generated sequence of random numbers.' |
| Allocation concealment (selection bias) | High risk | 'Individual assignment numbers were all placed in an opaque container to assure the concealment. The eligible women who had agreed to participate selected one of the numbers once, and were therefore allocated to either intervention group or control according to the list.' This process was open to selection bias as women could have re‐picked another number from the container. No audit process is possible with this system of randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants, clinicians and researchers were aware of group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Data collection by the author, who knew group allocation. Higher risk of bias for the "satisfaction" outcomes, compared to the clinical outcomes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Medical record data were collected and in‐hospital questionnaires were completed for 100% of sample |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported |
| Other bias | Low risk | No other sources of bias noted |