De Chateau 1977.
Methods | Randomized controlled trial (open random numbers table). | |
Participants | 62 healthy full‐term infants and their mothers. Group 1 primiparous mothers and their infants n = 22. Group 2 primiparous mothers and their infants n = 20. Group 3 multiparous mothers and their infants n = 20. | |
Interventions | Group 1: 15‐20 min of SSC during the first hour post birth. The infants were placed on the breast at 10 min post birth and assisted by the midwives with breastfeeding. Groups 2 and 3 = routine care. The dressed babies were placed in a crib at the mother's bedside or in her bed at 10 min post birth. | |
Outcomes | Observation of mother's behavior during breastfeeding at 36 hours post birth. Mother's and infant's behavior at 3 months during free play. Breastfeeding at 3 months, 1 year post birth. Mother's and infant's behavior during a physical exam and infant development at 12 months. | |
Notes | Study was done with middle‐income women in Sweden. 2‐arm trial with individual randomization (a 3rd group of women (multips) were also included as a comparison group in 1 of the reports but this group was not randomly allocated and is not included in the analyses). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Immediately after delivery, the midwife or auxiliary compared the number on the mother’s record with a coincidence table... placed in an office outside the delivery room – the primiparous mothers were randomly assigned”. |
Allocation concealment (selection bias) | High risk | Allocation according to open list after delivery. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It appeared that women were not aware that the intervention was part of a study, they were told that the observation was to examine mother‐infant behavior during breastfeeding. Staff providing care would be aware of the allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was stated that observation was carried out by staff who “did not know to which group the mother‐infant pairs belonged.” It was not clear whether other data were collected by blinded observers. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 42 women were randomized. 1 woman from the intervention group was not observed at 36 hours. At 1‐year follow‐up there were 33 remaining; of the 9 lost to follow‐up, 5 were described as belonging to the “lowest socioeconomic category”. There were some further missing data. |
Selective reporting (reporting bias) | Unclear risk | Data collected by observation difficult to interpret. It appeared that women could contribute different numbers of observations to mean scores. |
Other bias | Unclear risk | No baseline imbalance apparent. There was some discrepancy between results in the text and tables in 1 of the papers. Denominators for some outcomes were not clear. |