Abstract
BACKGROUND: A small, non-blinded, RCT (randomised controlled trial) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus (S. aureus)- colonized cracked nipples. We aimed to replicate the study with a more rigorous design and adequate sample size. METHODS: Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic (flucloxacillin) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples. We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples. RESULTS: We spent over twelve months submitting applications to five hospital ethics committees and seven funding bodies, before commencing the trial. Recruitment to the trial was very slow and only ten women were randomized to the trial after twelve months, and therefore the trial was stopped early. CONCLUSIONS: In retrospect we should have conducted a feasibility study, which would have revealed the low number of women in these Melbourne hospitals (maternity wards and breastfeeding clinics) with damaged nipples. The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested.
References
Feb 1, 1992·Geburtshilfe und Frauenheilkunde·F PetersS Ebel
Sep 28, 1991·Lancet·F Peters, D Flick-Filliés
Aug 1, 1995·Acta Paediatrica·K EvansK Simmer
Mar 1, 1994·Midwifery·U Waldenström, C A Nilsson
Jan 1, 1996·Gynecologic and Obstetric Investigation·L H AmirS J Farish
Mar 25, 1998·Midwifery·E P DuffyE Kershaw
May 30, 1998·Neuroscience Letters·J WaterhouseP Tucker
Oct 8, 1998·British Journal of Obstetrics and Gynaecology·J GunnD Young
Oct 24, 1998·The Medical Journal of Australia·J R KinlayS Kinlay
Nov 12, 1998·Archives of Pediatrics & Adolescent Medicine·N BrentL A Roth
Dec 1, 1999·Journal of Human Lactation : Official Journal of International Lactation Consultant Association·V Livingstone, L J Stringer
Mar 17, 2001·Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology·L J LevettR Meredith
Apr 24, 2001·Pediatric Surgery International·A AlbertL Morales
Jan 16, 2002·American Journal of Epidemiology·Betsy FoxmanKendra Schwartz
Jan 24, 2003·The Veterinary Quarterly·O Kerro DegoH Nederbragt
Jan 2, 2014·Breastfeeding Medicine : the Official Journal of the Academy of Breastfeeding Medicine·Miranda L BuckUNKNOWN CASTLE Study Team
Citations
Jul 23, 2011·BMC Pregnancy and Childbirth·Lisa H AmirMatthew S Payne
Jan 9, 2016·Journal of Caring Sciences·Mahnaz ShanaziFariba Esmaeli
Apr 20, 2007·International Breastfeeding Journal·Manizheh Sayyah MelliZohreh Tahmasebi
Aug 5, 2008·BMC Medical Research Methodology·Sirpa-Liisa HoviElina Hemminki
Aug 22, 2014·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Javad Yaghoobi Yeganeh ManeshFarshid Khadivar
Dec 17, 2014·The Cochrane Database of Systematic Reviews·Cindy-Lee DennisJo Watson
Oct 19, 2012·The Cochrane Database of Systematic Reviews·Maree A CrepinsekNeil A Smart
Aug 9, 2020·JMIR MHealth and UHealth·Diana M BondNatasha Nassar
Sep 29, 2020·The Cochrane Database of Systematic Reviews·Maree A CrepinsekFiona Stewart
May 21, 2017·BMC Pregnancy and Childbirth·Diana M BondNatasha Nassar
Mar 2, 2013·The Cochrane Database of Systematic Reviews·Shayesteh JahanfarCheong Lieng Teng