Livingstone 1999.
Study characteristics | ||
Methods | Design: prospective, randomised clinical trial. This study trial led basic breastfeeding advice with a combination of antibiotics and topical ointments. Setting: Canada, Vancouver Breastfeeding Center |
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Participants | Number of participants: (N = 84) Inclusion criteria: (N = 84). postpartum breastfeeding women with sore or cracked nipples. Mothers attending breastfeeding clinic for breastfeeding problems, cracked/sore nipples, positive Staphyloccocus aureus results Exclusion criteria: mothers with local or system spread of infection such as cellulitis, ascending lactiferous duct infection or mastitis |
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Interventions | Interventions: 4 intervention groups: 1. Optimal breastfeeding technique (basic breastfeeding advice) (N = 23) 2. Topical 2% mupirocin ointment to nipples, (N = 25) 3. Topical fusidic acid ointment to nipples, (N = 17) 4. Oral antibiotics ‐ cloxacillin/erythromycin, (N = 19) |
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Outcomes | Measured nipple symptoms, breast symptoms and mastitis | |
Notes | 100% compliance ‐ highly‐motivated breastfeeding women Intention‐to‐treat not used This study was stopped prematurely ‐ women who did not receive antibiotics perceived to have a higher rate of mastitis Authors contacted July 2020 to clarify study dates and declarations of interest; email address no longer active Dates of study: not stated Funding sources: funding in part was supported by the Department of Family Practice, Vancouver General Hospital. Berkowitz associates provided statistical consultation. Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 100 tags were alternatively labelled A, B, C, D and placed in an envelope. |
Allocation concealment (selection bias) | Low risk | Each case randomly assigned by drawing a tag from the envelope |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "This was an open study and outcome measures could be subjected to bias". Lack of blinding could influence women's and caregivers' perception of symptoms. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not specifically reported if outcome assessors were blinded (i.e. we did not know if people recording women's and caregivers' perception of symptoms were blinded) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses reported |
Selective reporting (reporting bias) | Low risk | Protocol publication was not common practice at the time but there was nothing to indicate selective reporting. |
Other bias | Low risk | Nothing to indicate any other source of bias |