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Table 1 Trials to prevent mastitis

From: A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389]

Author, date, country Subjects Aim Control(presence/absence/type) Intervention Sample size Outcome: mastitis
Hesseltine et al 1948, USA[3] Patients at the Chicago Lying-In Hospital: July – Sept 1946 Does topical penicillin ointment on mother's nipples prevent mastitis? Historical controls: July 1933 to Dec 1946 Penicillin ointment (2,000 units per treatment) on nipples after feeds (6–8 weeks) Intervention 865; Controls 40,629 Intervention: 53 women with mastitis, 6.1%, and 18 with abscess, 2%; Control: 210 women with abscess, 0.51%
Sasse 1973, Germany (in German)[4] Postnatal women in the Frauenclinik der Freien Universitat Berlin-Charlottenburg, 1967 Does an antibiotic spray to mother's nipples prevent mastitis? Historical controls Nabectin Puder Spray(neomycin and bacitracin) applied to nipples, plus hand disinfection for nurses and mothers before handling breasts. Intervention130; Controls100 Intervention: 7% mastitis by 2 months; Control: 23%
Berger & Pusteria 1981 Switzerland[5] Postnatal women in the Women's Hospital, University of Berne(reported in 1962 [22]) Does nipple ointment prevent mastitis? One group used a nipple ointment without the active ingredient. Not a RCT. Six nipple ointments:   
     (a) boric-acid Vaseline with Peruvian balsam, (a) 1,000 (a) 1.5%
     (b) chlortetracycline, (b) 1,000 (b) 0.7%
     (c) chlorquinadol ointment, (c) 1,000 (c) 0.4%
     (d) base of chlorquinadol ointment (without active ingredient), (d) 1,000 (d) 0.4%
     (e) calcium pantothenicum, (e) 2,000 (e) 0.8%
     (f) dihydrofolliculin benzoate and tyrothrycin (f) 1,500 (f) 0.5%
Kovalev 1990, Russia (in Russian)[6]   Does treating cracked nipples with laser therapy prevent mastitis? Unclear from abstract Laser treatment to damaged nipples 329 women with damaged nipples Intervention reduced mastitis from 18.6% to 3.7%
Sytnik 1990, Russia [8] (in Russian)[8]   Does bifidobacterium prevent mastitis? Unclear from abstract Bifidobacterium 160 women Mastitis reduced from 6.88% to 1.25%
Peters and Flick-Fillies1991, Germany[7,23] Postnatal women in St Hildegardis Hospital, Mainz, 1989–1991 Does the use of bedside hand disinfectant prevent mastitis? Historical controls: 12 months (Sep 1989-Jun 1990, May-Jun 1991) Bed-side disinfectant dispensers: 12 months (Jul 1990-April 1991, Jul-Aug 1991) Intervention: 1095; Control 1230 Intervention 8 women, 0.65%; Control 32 women 2.9%; p <0.001
Waldenstrom and Nilsson 1994, Sweden[9] Women giving birth at South Hospital, Stockhom Is birth centre care beneficial for breastfeeding? Does it increase duration and reduce complications (including mastitis)? RCT Birth centre care compared to standard care Intervention 617; Control 613. Postal questionnaire 2 months postpartum. "Milk stasis" (fever and swelling, redness and tenderness in one of the breasts): Intervention 26%; Control 19% (p = 0.002). "Mastitis" (infective breast treated with antibiotics): Intervention 1%, Control < 1% (p = 0.07)
Jonsson & Pulkkinen 1994, Finland[10] Women in South-West Finland Does antenatal / postnatal breast massage prevent mastitis? Concurrent controls. "Breast massage with the hands, a brush, a coarse towel or a sponge before and / or after delivery" Intervention 255, Control 400. Questionnaire 5–12 weeks postpartum at outpatient visit. Overall incidence of mastitis was 24%. No difference in incidence of mastitis (no details given). "This physical training of the nipples neither decreases or increases the frequency of mastitis" (p86)
Evans et al 1995, Australia[11] Postnatal women at Flinders Medical Centre, Adelaide Does prolonged feeding on one breast per feed reduce breastfeeding complications, including mastitis? Historical controls: 5 months Advice to feed from one breast per feed and only offer the second breast if the baby still showed signs of hunger rather than standard care of both breasts at each feed: 5 months Intervention 150; Control 152 Telephone interview at 6 months postpartum: Intervention 15%; Control 18%
Gunn et al 1998, Australia[12] Women giving birth in one metropolitan hospital and one rural hospital in Victoria, 1995 Does an early visit to a general practitioner reduce problems (including mastitis) compared to the standard six-week postnatal visit? RCT General practitioner visit at one week compared to standard six week visit Intervention 232; Control 243 Postal questionnaire at 3 months. Intervention 11.6%; Control 15.6% (Odds Ratio 0.71, 95%CI: 0.42, 1.20)
Livingstone & Stringer, Canada[13] Women attending the Vancouver Breastfeeding Center with a cracked nipple and S. aureus positive culture. Are oral or topical antibiotics more effective in the treatment of S. aureus-colonized cracked nipples than standard care? RCT (not blind to treatment group or outcome) 4 groups:   Assessment at 7 days. Oral antibiotics: 1/19, 5%; Other groups: 16/65 (25%) (Fisher exact 0.1)
     (a) oral antibiotics (a) 19  
     (b) topical mupirocin (b) 25  
     (c) topical fusidic acid (c) 17  
     (d) standard care (d) 23