| Methods |
Randomized controlled trial. |
| Participants |
44 full‐term infants and their mothers immediately post birth. |
| Interventions |
Group a) 76‐85 min of SSC with the mother, b) infant in a cot for 76‐85 min, c) infant in a cot for 35 min then SSC for 45 min. |
| Outcomes |
Duration of crying, axillary temperature 90 min post birth. |
| Notes |
Study was done in Madrid, Spain. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described “allocated randomly”.
|
| Allocation concealment (selection bias) |
Unclear risk |
Not described (allocation was before delivery but women and staff were not informed of the allocation until after delivery). |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Participants and staff were not blinded. It is not clear whether knowledge of allocation would have affected maternal behavior and responses (for those in the “cot” group, women were asked not to move the baby).Staff providing care may have altered other aspects of care. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Outcome assessors were blinded (blind assessment of audiotapes – although presumably they would also hear the mother and other noise so may have been able to ascertain group assignment). |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Due to mechanical failures there were missing data for the primary outcome.44 women were randomized and audiotape data were available for 33 (75%). |
| Selective reporting (reporting bias) |
Unclear risk |
Assessed from published study report. |
| Other bias |
Unclear risk |
Describe any baseline in balance: Not apparent, but sample size was small so imbalances between groups although not statistically significant may have been important (e.g. cot group 7/14 primips, s to s 5/15 primips). |
