De Oliveira 2006.
Study characteristics | ||
Methods | Design: randomised controlled trial. Setting: Porto Alegre, Brazil (women were recruited from June to November 2003) |
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Participants | Number of participants: (N = 211) breastfeeding mother‐infant pairs. Inclusion criteria: healthy non‐twin newborns with birthweight ≥ 2500 g Exclusion criteria: mother‐infant pairs unable to stay together due to a health concern in either the mother or the infant |
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Interventions | Intervention: breastfeeding education session (30 minutes) with a lactation consultant and an experienced breastfeeding nurse in hospital (N = 74) Control: usual care (N = 137) All women received a follow‐up home visit at day 7 and day 30. |
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Outcomes | Measures of exclusive breastfeeding rates and breastfeeding‐related problems Measure of mastitis, sore nipples and engorgement | |
Notes | No contact details available for the trial authors Dates of study: June to November 2003 Funding sources: not stated Declarations of interest: "No reported competing interests" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned using 2 different coloured balls from a bag, 1 colour for the intervention, 1 colour for the control |
Allocation concealment (selection bias) | Unclear risk | 2 different coloured balls from a bag, 1 colour for the intervention, 1 colour for the control |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind women or caregivers; self‐reported outcomes could be affected |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The researchers responsible for the breastfeeding evaluations did not participate in the intervention and were blinded to the group to which the mother‐infant pairs had been assigned." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Between 5% and 9.9%. The original number of participants in the experimental group and the control group was 74 and 137, respectively. At the time of data analysis, there had been a loss of participants in both groups, 3 participants in the experimental group leaving 71 women and 5 women in the control group leaving 132 women. |
Selective reporting (reporting bias) | Low risk | Protocol publication was not common practice at the time. No evidence of selective reporting |
Other bias | Low risk | No apparent evidence of other bias |