Pugh 2002.
Methods | RCT 2 arms with individual randomisation. | |
Participants | Setting: the trial was conducted between April 1999 and February 2000 in a large hospital in the USA. Inclusion criteria 41 women on low incomes (receiving financial medical assistance support). Women were recruited in hospital after the birth of their baby. |
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Interventions | Women in both groups received breastfeeding support from hospital nurses and all women had access to telephone advice. Women whose babies were born on weekdays were visited by a lactation consultant. Intervention group (21 women) women received extra visits from the community health nurse or one of the peer counsellor team daily while they were in hospital then at home during weeks 1,2 and 4. In addition peer counsellors provided telephone support twice weekly until the babies were 8 weeks old and then weekly until the baby was 6 months old (even if the mother had stopped breastfeeding). Control group (20 women) Usual care. |
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Outcomes | Duration of breastfeeding, duration of exclusive breastfeeding, costs of care, health service utilisation. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | "assigned randomly by a sealed envelope technique.” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No women appeared to be lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Not clear, assessment from published study report. |
Other bias | Unclear risk | Not apparent. |