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. 2020 Sep 29;2020(9):CD007239. doi: 10.1002/14651858.CD007239.pub4

De Oliveira 2006.

Study characteristics
Methods Design: randomised controlled trial.
Setting: Porto Alegre, Brazil (women were recruited from June to November 2003)
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
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.
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"
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