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Intervenciones para la prevención de la mastitis después del parto

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Referencias

Referencias de los estudios incluidos en esta revisión

Amir 2004 {published data only}

Amir LH, Lumley J, Garland SM. A failed RCT to determine if antibiotics prevent mastitis: cracked nipples colonized with staphylococcus aureus: a randomised treatment trial [ISRCTN65289389]. BMC Pregnancy and Childbirth. 2004;4(19):1‐6. [DOI: 10.1186/1471‐2393‐4‐19]

De Oliveira 2006 {published data only}

De Oliveira LD, Giugliani ERJ, do Espirito Santo LC, Franca MC, Weigert EML, Kohler C, et al. Effect of intervention to improve breastfeeding technique on the frequency of exclusive breastfeeding and lactation‐related problems. Journal of Human Lactation 2006;22(3):315‐21. [DOI: 10.1177/08903344062900221]

Livingstone 1999 {published data only}

Livingstone V, Stringer LJ. The treatment of staphylococcus aureus infected sore nipples: a randomised comparative study. Journal of Human Lactation 1999;15(3):241‐6. [DOI: 10.1177/089033449901500315]

Sebitloane 2008 {published data only}

Sebitloane HM, Moodley J, Esterhuizen TM. Prophylactic antibiotics for the prevention of postpartum infectious morbidity in women infected with human immunodeficiency virus: a randomized controlled trial. American Journal of Obstetrics and Gynecology2008; Vol. 198, issue 2:189.e1‐189.e6.

Svensson 2004 {published data only}

Svensson K, Lange S, Lonnroth I, Widstrom AM, Hanson LA. Induction of anti‐secretory factor in human milk may prevent mastitis. Acta Paediatrica 2004;93(9):1228‐31. [ISSN 0803‐5253]

Referencias de los estudios excluidos de esta revisión

Blaikeley 1953 {published data only}

Blaikeley J, Clarke S, MacKeith R, Ogden K M. Breast‐feeding: factors affecting success. Journal of Obstetrics and Gynaecology of the British Empire 1953;60:657‐69.

Bystrova 2007 {published data only}

Bystrova K, Widstrom AM, Matthiesen AS, Ransjo‐Arvidson AB, Welles‐Nystrom B, Vorontsov I, et al. Early lactation performance in primiparous and multiparous women in relation to different maternity home practices. A randomised trial in St. Petersburg. International Breastfeeding Journal 2007;2(9):14.

Centuori 1999 {published data only}

Centuori S, Burmaz T, Ronfani L, Fragiacomo M, Quintero S, Pavan C, et al. Nipple care, sore nipples, and breastfeeding: a randomised trial. Journal Human Lactation 1999;15:125‐30.

Crepinsek 2008 {published data only}

Crepinsek AM. Self‐management versus usual care for the treatment of mastitis following childbirth: a randomised control trial. Australian New Zealand Clinical Trials Register (www.anzctr.org.au) (accessed 19 February 2008).

Evans 1995 {published data only}

Evans K, Evans R, Simmer K. Effect of the method of breast feeding on breast engorgement, mastitis and infantile colic. Acta Paediatrica 1995;84(8):849‐52.

Filteau 1999 {published data only}

Filteau SM, Lietz G, Mulokozi G, Bilotta S, Henry CJ, Tomkins AM. Milk cytokines and subclinical breast inflammation in Tanzanian women: effects of dietary red palm oil or sunflower oil supplementation. Immunology 1999;97:595‐600.

Forster 2004 {published data only}

Forster D, McLachlan H, Lumley J, Beanland C, Waldenstrom U, Amir L. Two mid‐pregnancy interventions to increase the initiation and duration of breastfeeding: a randomised controlled trial. Birth 2004;31(3):176‐82.
Forster D, McLachlan H, Lumley J, Beanland C, Waldenstrom U, Harris H, et al. ABFAB. Attachment to the breast and family attitudes to breastfeeding. The effect of breastfeeding education in the middle of pregnancy on the initiation and duration of breastfeeding: a randomised controlled trial. BMC Pregnancy and Childbirth 2003;3:5.
Forster DA, McLachlan HL, Lumley J, Beanland CJ, Waldenstrom U, Short RV, et al. ABFAB: attachment to the breast and family attitudes towards breastfeeding. The effect of breastfeeding education in the middle of pregnancy on the duration of breastfeeding: a randomised controlled trial. Perinatal Society of Australia and New Zealand 7th Annual Congress; 2003 March 9‐12; Tasmania, Australia. 2003:A70.

Frank 1987 {published data only}

Frank DA, Wirtz SJ, Sorenson JR, Heeren T. Commercial discharge packs and breast‐feeding counselling: effects on infant‐feeding practices in a randomised trial. Pediatrics 1987;80(6):845‐54.

Gomo 2003 {published data only}

Gomo E, Filteau SM, Tomkins AM, Ndhlovu P, Michaelsen KF, Friis H. Subclinical mastitis among HIV‐infected and uninfected Zimbabwean women participating in a multi micronutrient supplementation trial. Transactions of the Royal Society of Tropical Medicine and Hygiene 2003;97(2):212‐6.

Gunn 1998 {published and unpublished data}

Gunn J, Lumley J, Chondros P, Young D. Does an early postnatal check‐up improve maternal health: results from a randomised trial in Australian general practice. BJOG: an international journal of obstetrics and gynaecology 1998;105(9):991‐7.

Hager 1996 {published data only}

Hager WD, Barton JR. Treatment of sporadic acute puerperal mastitis. Infectious Diseases in Obstetrics and Gynecology 1996;4(2):97‐101.

Harvey 1988 {published data only}

Harvey D. Controlled trial of chlorhexidine in aerosol spray for the prevention of sore nipples. Personal communication1988.

Herd 1986 {published data only}

Herd B, Feeney JG. Two aerosol sprays in nipple trauma. Practitioner 1986;230:31‐8.

Homer 2001 {published data only}

Homer CSE, Davis GK, Brodie PM, Sheehan A, Barclay LM, Wills J, et al. Collaboration in maternity care: a randomised controlled trial comparing community‐based continuity of care with standard hospital care. BJOG: an International journal of obstetrics and gynaecology 2001;108(1):16‐22.

Kramer 2001 {published data only}

Kramer MS, Chalmers B, Hodnett ED, Sevkovskaya Z, Dzikovich I, Shapiro S, et al. Promotion of Breastfeeding Intervention Trial (PROBIT): a randomised trial in the Republic of Belarus. JAMA 2001;285(4):413‐20.

Kvist 2004 {published data only}

Kvist LJ, Wilde Larsson B, Hall‐Lord ML, Rydhstroem H. Effects of acupuncture and care interventions on the outcome of inflammatory symptoms of the breast in lactating women. International Nursing Review 2004;51(1):56‐64.

Kvist 2007 {published data only}

Kvist LJ, Hall‐Lord ML, Rydhstroem H, Larsson BW. A randomised‐controlled trial in Sweden of acupuncture and care interventions for the relief of inflammatory symptoms of the breast during lactation. Midwifery 2007;23(2):184‐95.

Lawlor‐Smith 1997 {published data only}

Lawlor‐Smith C, McIntyre E, Bruce J. Effective breastfeeding support in general practice. Australian Family Physician 1997;26(5):573‐80.

Lumley 2006 {published data only}

Lumley J, Watson L, Small R. PRISM (Program of Resources, Information and Support for Mothers): a community‐randomised trial to reduce depression and improve women's physical health six months after birth. BMC Public Health 2006;6:37.

Luttkus 1997 {published data only}

Luttkus A, Fiebelkorn J, Dudenhausen W. Antibiotic prophylaxis in cases of emergency caesarean section. Geburtshilfe und Frauenheilkunde 1997;57(9):510‐4.

McLachlan 1991 {published data only}

McLachlan Z, Milne EJ, Lumley J, Walker BL. Ultrasound treatment for breast engorgement: a randomised double blind trial. Australian Journal of Physiotherapy 1991;37(1):23‐8.

Meah 2001 {published data only}

Meah S. A breastfeeding intervention increased breast feeding and reduced GI tract infections and atopic eczema. Evidence‐Based Nursing 2001;4(4):106.

Neifert 1990 {published data only}

Neifert M, DeMarzo S, Seacat J, Young D, Leff M, Orleans M. The influence of breast surgery, breast appearance, and pregnancy‐induced breast changes on lactation sufficiency as measured by infant weight gain. Birth 1990;17(1):31‐8.

Nicholson 1985 {published data only}

Nicholson W. Cracked nipples in breastfeeding mothers ‐ a randomised trial of three methods of management. Nursing Mothers Association of Australia Newsletter1985; Vol. 21:7‐10.

Nicholson 1993 {published data only}

Nicholson WL. The use of nipple shields by breastfeeding women. Australian College of Midwives Incorporated Journal 1993;6(2):18‐24.

Nikodem 1993 {published data only}

Nikodem VC, Danziger D, Gebka N, Gulmezoglu AM, Hofmeyr GJ. Do cabbage leaves prevent breast engorgement? A randomised controlled study. Birth 1993;20(2):61‐4.

Phillips 1975 {published data only}

Phillips WP. Prevention of postpartum breast engorgement: double‐blind comparison of chlorotrianisene 72 mg. and placebo. Journal of the Arkansas Medical Society 1975;72(4):163‐7.

Roberts 1995 {published data only}

Roberts KL. A comparison of chilled cabbage leaves and chilled gel packs in reducing breast engorgement. Journal of Human Lactation 1995;11(1):17‐20.

Roberts 1998 {published data only}

Roberts KL, Reiter M, Schuster D. Effects of cabbage leaf extract on breast engorgement. Journal of Human Lactation 1998;14(3):231‐6.

Schurz 1978 {published data only}

Schurz AR, Kobermann M. Comparison of nipple care in the puerperium with powder and ointment. Geburtshilfe und Frauenheilkunde 1978;38:573‐6.

Swift 2003 {published data only}

Swift K, Janke J. Breast binding... is it all that it's wrapped up to be?. Journal of Obstetric, Gynecologic, and Neonatal Nursing 2003;32(3):332‐9.

Thomsen 1984 {published data only}

Thomsen AC, Espersen T, Maigaard S. Course and treatment of milk stasis, noninfectious inflammation of the breast, and infectious mastitis in nursing women. American Journal of Obstetrics and Gynecology 1984;149:492‐5.

Waldenstrom 1994 {published data only}

Waldenstrom U, Nilsson CA. No effect of birth centre care on either duration or experience of breast feeding, but more complications: findings from a randomised controlled trial. Midwifery 1994;10:8‐17.

Referencias de los estudios en espera de evaluación

Gensch 2006 {published data only}

Gensch M, Wockel A, Abou‐Dakn M. Effects of lanolin on nipple pain of breastfeeding mothers. Geburtshilfe und Frauenheilkunde 2006;67:43.

Bell 1998

Bell KK, Rawlings NL. Promoting breast‐feeding by managing common lactation problems. Nurse Practitioner 1998;23(6):102‐4, 106, 109‐10.

Chezem 2003

Chezem J, Friesen C, Boettcher J. Breastfeeding knowledge, breastfeeding confidence, and infant feeding plans: effects on actual feeding practices. Journal of Obstetric, Gynecologic, and Neonatal Nursing 2003;32(1):40‐7.

Chua 1994

Chua S, Arulkumaran S, Lim I, Selemat N, Ratnam SS. Influence of breastfeeding and nipple stimulation on postpartum uterine activity. British Journal of Obstetrics and Gynaecology 1994;101:804‐5.

Cummings 1993

Cummings R, Klineberg R. Breastfeeding and other reproductive factors and the risk of hip fractures in elderly women. International Journal of Epidemiology 1993;22:684‐91.

Deeks 2001

Deeks JJ, Altman DG, Bradburn MJ. Statistical methods for examining heterogeneity and combining results from several studies in meta‐analysis. In: Egger M, Davey Smith G, Altman DG editor(s). Systematic reviews in health care: meta‐analysis in context. London: BMJ Books, 2001.

Dener 2003

Dener C, Inan A. Breast abscesses in lactating women. World Journal of Surgery 2003;27:130‐3.

Dennis 2008

Dennis CL, Allen K, McCormick FM, Renfrew MJ. Interventions for treating painful nipples among breastfeeding women. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD007366]

Dewey 1999

Dewey KG. Maternal weight loss patterns during prolonged lactation. Australian Journal of Clinical Nutrition 1999;58:162‐6.

Dyson 2005

Dyson L, McCormick FM, Renfrew MJ. Interventions for promoting the initiation of breastfeeding. Cochrane Database of Systematic Reviews 2005, Issue 2. [DOI: 10.1002/14651858.CD001688.pub2]

Fetherston 1997

Fetherston C. Characteristics of lactation mastitis in a Western Australian cohort. Breastfeeding Review 1997;5(2):5‐11. [0729‐2759 (Print)]

Fetherston 1998

Fetherston C. Risk factors for lactation mastitis. Journal of Human Lactation 1998;14(2):101‐9.

Flores 2002

Flores M, Filteau S. Effect of lactation counselling on subclinical mastitis among Bangladeshi women. Annals of Tropical Paediatrics 2002;22(1):85‐8. [0272‐4936 (Print)]

Foxman 1994

Foxman B, Schwartz K, Looman SJ. Breastfeeding practices and lactation mastitis. Social Science & Medicine 1994;38(5):755‐61. [0277‐9536 (Print)]

Foxman 2002

Foxman B, D'Arcy H, Gillespie B, Bobo JK, Schwartz K. Lactation mastitis: occurrence and medical management among 946 breastfeeding women in the United States. American Journal of Epidemiology 2002;155(2):103‐14. [0002‐9262 (Print)]

Gurtovoi 1979

Gurtovoi BL. Principles of treatment of postpartum mastitis. Akusherstvo i Ginekologiia 1979;11:40‐4.

Guttman 2000

Guttman N, Zimmerman DR. Low‐income mothers' views on breastfeeding. Social Science & Medicine 2000;50:1457‐73.

Higgins 2008

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane‐handbook.org.

Inch 2000

Inch S, von Xylander S. Mastitis causes and management. Geneva: WHO, 2000.

Inch 2006

Inch S. Breastfeeding problems: prevention and management. Community Practitioner 2006;79(5):165‐7. [1462‐2815 (Print)]

Jahanfar 2009

Jahanfar S, Ng CJ, Teng CL. Antibiotics for mastitis in breastfeeding women. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD005458.pub2]

Kinlay 2001

Kinlay JR, O'Connell DL, Kinlay S. Risk factors for mastitis in breastfeeding women: results of a prospective cohort study. Australian and New Zealand Journal of Public Health 2001;25(2):115‐20. [1326‐0200 (Print)]

Kramer 2002

Kramer MS, Kakuma R. Optimal duration of breastfeeding. Cochrane Database of Systematic Reviews 2002, Issue 1. [DOI: 10.1002/14651858.CD003517]

Kulakov 2004

Kulakov AA, Shkoda SM, Astasvov EI, Protasenko PYA, Petrov VI. Lactation mastitis: problems and perspectives. Khiruugiia 2004;6:36‐8.

Lefebvre 2008

Lefebvre C, Eisinga A, McDonald S, Paul N. Enhancing access to reports of randomized trials published world‐wide – the contribution of EMBASE records to the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library. Emerging Themes in Epidemiology.2008; Vol. 5:13.

Lumbiganon 2007

Lumbiganon P, Martis R, Laopaiboon M, Festin MR, Ho JJ, Hakimi M. Antenatal breastfeeding education for increasing breastfeeding duration. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD006425]

MacDonald 2003

MacDonald A. Is breast best? Is early solid feeding harmful?. Journal of the Royal Society of Health 2003;123(3):169‐74. [0264‐0325 (Print)]

Melton 1993

Melton LJ, Bryant SC, Wahner HW, O'Fallon WM, Malkasian GD. Influence of breastfeeding and other reproductive factors on bone mass later in life. Osteoporosis International 1993;3:76‐83.

Michie 2003

Michie C, Lockie F, Lynn W. The challenge of mastitis. Archives of Disease in Childhood 2003;88(9):818‐21. [1468‐2044 (Electronic)]

Mitra 2004

Mitra AK, Khoury AJ, Hinton AW, Carothers C. Predictors of breastfeeding intention among low‐income women. Maternal and Child Health Journal 2004;8(2):65‐70.

Potter 2005

Potter B. A multi‐method approach to measuring mastitis incidence. Community Practitioner 2005;78:169‐73.

RevMan 2008 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.

Riordan 1990

Riordan JM, Nichols FH. A descriptive study of lactation mastitis in long‐term breastfeeding women. Journal of Human Lactation 1990;6(2):53‐8. [0890‐3344 (Print)]

Rosenblatt 1993

Rosenblatt K, Thomas D. Lactation and the risk of epithelial ovarian cancer. International Journal of Epidemiology 1993;22:192‐7.

Schwartz 2002

Schwartz K, D'Arcy HJS, Gillespie B, Bobo J, Longeway M, Foxman B. Factors associated with weaning in the first 3 months postpartum. Journal of Family Practice 2002;51(5):439‐44. [00943509]

Semba 2000

Semba RD. Mastitis and transmission of human immunodeficiency virus through breast milk. Annals of the New York Academy of Sciences 2000;918:156‐62. [0077‐8923 (Print)]

Siskind 1997

Siskind V, Green A, Bain C, Purdie D. Breastfeeding, menopause, and epithelial ovarian cancer. Epidemiology 1997;8:188‐91.

Spowart 2004

Spowart K, Heinig J, Ishii K. Dealing with mastitis. Journal of Human Lactation 2004;20(2):238‐9.

Tanchev 2004

Tanchev S, Vulkova S, Georgieva V, Gesheva Iu, Tsvetkov M. Lansinoh in the treatment of sore nipples in breastfeeding women. Akusherstvo i Ginekologiia 2004;43 Suppl 3:27‐30.

Thompson 2005

Thompson J. Breastfeeding: benefits and implications. Part two. Community Practitioner 2005;78(6):218‐9. [1462‐2815 (Print)]

Vogel 1999

Vogel A, Hutchison BL, Mitchell EA. Mastitis in the first year postpartum. Birth 1999;26(4):218‐25. [0730‐7659 (Print)]

Wong 2006

Wong SS, Wilczynski NL, Haynes RB. Optimal CINAHL search strategies for identifying therapy studies and review articles. Journal of Nursing Scholarship 2006;38(2):194‐9. [PUBMED: 16773925]

World Health Organization 2008

WHO, UNICEF, USAID, AED, UCDAVIS, IFPRI. Indicators for assessing infant and young child feeding practices. Part 1. Definitions. Conclusions of a consensus meeting; 2007 Nov 6‐8; Washington DC, USA. Geneva: World Health Organization, 2008. [ISBN: 978 92 4 159666 4]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Amir 2004

Methods

Randomised controlled trial.

Participants

Breastfeeding postpartum women (N = 10) with cracked nipples colonised with Staphylococcus aureus.

Setting: hospitals in Melbourne, Australia.

Inclusion criteria: lactating women with Staphylococcus aureus‐colonised nipples wishing to breastfeed.

Exclusion criteria: cracked nipples that were not colonised with Staphylococcus aureus.

Interventions

Prophylactic antibiotics (flucloxacillin capsules taken for 7 days); N = 5 versus placebo (capsules with glucose powder taken for 7 days); N = 5.

Women with a positive nipple culture for Staphylococcus aureus had a follow‐up visit at 1 week.

Women with negative nipple cultures had telephone follow up at 1 week.

All participants had a final telephone interview at 6 weeks.

Outcomes

Mastitis study aborted at 12 months due to poor intervention compliance and lack of eligible participants.

Notes

After 12 months, only 10 of the planned total of 133 women had been randomised to the trial and so the trial was stopped early.

The author for this trial was contacted to clarify risks of bias.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The pharmacist used a random numbers table to label the capsules (placebo or active); sequence was stratified by hospitals in blocks of 10.

Allocation concealment (selection bias)

Low risk

Third party (pharmacist).

Blinding (performance bias and detection bias)
All outcomes

Low risk

Capsules were of identical appearance and so participants and investigators were blinded.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

2 women (2/10) dropped out of the study as they did not wish to take medications ‐ both women had been allocated to the placebo group.

Selective reporting (reporting bias)

Unclear risk

No evidence of selective reporting.

Other bias

Unclear risk

Trial stopped early.

De Oliveira 2006

Methods

Randomised controlled trial.

Participants

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.

Setting: Porto Alegre, Brazil (women were recruited from June to November 2003).

Interventions

Breastfeeding education session (30 minutes) with an lactation consultant and an experienced breastfeeding nurse in hospital (N = 74) versus usual care (N = 137).

All women received a follow‐up home visit at day 7 and day 30.

Outcomes

Measure of exclusive breastfeeding rates, breastfeeding related problems. Measure of mastitis, sore nipples and engorgement.

Notes

Attempts to contact the authors were unsuccessful.

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 (performance bias and detection bias)
All outcomes

Unclear risk

Researchers responsible for assessment blinded to intervention group assignment. Not feasible for participants and clinician.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Between 5%‐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)

Unclear risk

No evidence of selective reporting

Other bias

Unclear risk

No apparent evidence of other bias.

Livingstone 1999

Methods

This study trial led basic breastfeeding advice with a combination of antibiotics and topical ointments.

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 were excluded.

Participants

N = 84. Postpartum breastfeeding women with sore or cracked nipples.

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.

Outcomes

Measured nipple symptoms, breast symptoms and mastitis.

Notes

100% compliance ‐ highly‐motivated breastfeeding women. Women that presented with mastitis were excluded from the study. Intention‐to‐treat not used.

This study was stopped prematurely ‐ women who did not receive antibiotic perceived to have a higher rate of mastitis.

An attempt to contact this author to clarify findings was unsuccessful.

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 (performance bias and detection bias)
All outcomes

High risk

Open unblinded study.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No losses reported.

Selective reporting (reporting bias)

Unclear risk

No evidence of selective reporting.

Other bias

Unclear risk

Trial was stopped early.

Sebitloane 2008

Methods

Randomised controlled trial of women who planned to have caesarean sections and who were HIV infected. This study trial led antibiotics versus placebo.

Participants

N = 615, HIV infected women > 18 years, ≥ 36 weeks' gestation with anticipated vaginal delivery at King Edward VIII and Addington Hospital in Durban, South Africa between February 2003 and May 2005.

675 delivered at the hospitals in the study and were eligible for randomisation. 60 had a planned caesarean section and were excluded. 305 were randomised and received cefoxitin and 310 were randomly assigned the placebo. Following this, a further 92 women from the intervention group and 99 from the placebo group were excluded because they had an emergency caesarean delivery.

Interventions

2 gm dose of cefoxitin intravenously over 20 minutes during active labour versus a water placebo administered over the same period of time.

Outcomes

Of the 213 women assigned randomly to the cefoxitin group, 182 (85%) returned for the follow‐up evaluation at 1 week and 184 (86%) returned at 2 weeks. Of the 212 women assigned the placebo, 180 (85%) returned for the follow up at 1 week and 178 (84%) returned at the 2 week for follow up.

Notes

Clinicians blinded to intervention. Women were excluded if they had an emergency caesarean delivery after randomisation. The randomised groups were comparable with regards age, parity, gestational age at delivery and most baseline haematology.

An attempt to contact this author to clarify findings was unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Computer generated by statistician. Syringes labelled D001‐D686; participants were given the drug during labour according to the next available number.

Allocation concealment (selection bias)

Low risk

The statistician generated a computer‐based allocation of each study numbered 1‐686 into either group 1 or 2 which represented either cefoxitin or placebo. Only the pharmacist was aware of the drug code for the duration of the study.

Blinding (performance bias and detection bias)
All outcomes

Unclear risk

Blinded to clinicians.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Incomplete outcome data > 20%. The original number of participants in the study was 716, of which 675 delivered within the study premises. 60 of these women were not randomised. Finally 615 women were randomised, with 305 women in the experimental group and 310 in the control group. The 1‐week follow up resulted in 182 participants in the experimental group and 180 in the control group. At the 2‐week follow up there were 184 in the experimental group and 178 in the control group.

Selective reporting (reporting bias)

Unclear risk

No evidence of selective reporting

Other bias

Unclear risk

No apparent evidence of other bias.

Svensson 2004

Methods

This study trial led the use of anti‐secretory factor (AF) in cereal to prevent mastitis. Data collected from April to August 2002. All mothers were Swedish or raised in Sweden. Duration of follow up 5 weeks.

Participants

N = 40 postpartum breastfeeding women that had normal deliveries and have healthy full ferm infants, were randomly divided into 2 groups. Participants were breastfeeding or intended to breastfeed.

Interventions

Anti‐secretory factor in cereal versus similar cereal without the AF. Experimental group N = 12, control group N = 16 (11 mothers dropped out and one mother failed to give a milk sample from the control group).

Outcomes

Incidence of mastitis between groups.

Notes

Participants requested to eat 50 g of cereal for a period of 5 weeks. Duration of follow up was 5 weeks. No difference between the groups, regarding background, obstetric data, age, education, parity, type of anaesthesia used during the delivery, child sex and birth rate. Loss of participants to follow up > 20%.

To date, attempts to contact the authors have been unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomly assigned (sealed envelopes that were opened consecutively) to 1 of 2 groups. (further information not available at this stage, unable to contact the author).

Allocation concealment (selection bias)

Unclear risk

Sealed envelopes that were opened consecutively.

Blinding (performance bias and detection bias)
All outcomes

Low risk

Blinding to participants, cereal used looked the same. Researchers and participants blinded to which cereal was allocated. Randomising sequence concealed until data were collected and laboratory analysis was performed.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Incomplete outcome data > 20%. The original number of participants in the study was 40. 11 of these participants dropped out in the first 2 weeks. 7 mothers in the experimental group and 3 in the control group. 1 mother was excluded because of incorrect compliance of the intervention. The final number for the experimental group was 12 mothers and 17 for the control group. 1 of the mothers in the control group failed to provide a milk sample at the end of the study. Final data analysis was on 12 mothers from the experimental group and 17 from the control group.

Selective reporting (reporting bias)

Unclear risk

No evidence of selective reporting

Other bias

Unclear risk

No apparent evidence of other bias.

GP: general practitioner

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Blaikeley 1953

This study is not a randomised controlled trial and does not meet the requirements necessary for random allocation, concealment or blinding.

Bystrova 2007

This is not a trial of mastitis prevention. It is an RCT on the effect of different postnatal ward practices on lactation performance.

Centuori 1999

This is not a trial of mastitis prevention. It is an RCT on treating sore nipples.

Crepinsek 2008

Trial stopped.

Evans 1995

This study is not a randomised controlled trial and does not meet the requirements necessary for random allocation, concealment or blinding.

Filteau 1999

This is not a trial of mastitis prevention. It is an RCT of postpartum maternal vitamin A supplementation.

Forster 2004

This is an RCT of strategies to increase breastfeeding initiation and duration.

Frank 1987

This is not a trial of mastitis prevention. It is an RCT of discharge packs and counselling to increase breastfeeding duration.

Gomo 2003

This is a micronutrient RCT looking at preventing 'subclinical' mastitis.

Gunn 1998

This trial did not evaluate interventions for preventing mastitis ‐ it is a trial comparing early postnatal check up with a GP (at one week) with the usual 6 week check up.

Hager 1996

Treatment of mastitis, not prevention.

Harvey 1988

This is an RCT/quasi‐RCT for preventing sore nipples.

Herd 1986

This is an RCT for treating nipple trauma.

Homer 2001

This is a continuity of care RCT.

Kramer 2001

This is an RCT of breastfeeding promotion.

Kvist 2004

This is a treatment trial.

Kvist 2007

This is a treatment trial.

Lawlor‐Smith 1997

This is not an RCT.

Lumley 2006

This is an RCT of resources, information and support for postpartum women.

Luttkus 1997

This is an RCT of antibiotic prophylaxis for caesarean section.

McLachlan 1991

This is an RCT of ultrasound treatment for breast engorgement.

Meah 2001

This is not an RCT. It is a letter re Kramer 2001.

Neifert 1990

This is not an RCT.

Nicholson 1985

This is an RCT of treating cracked nipples.

Nicholson 1993

This is not an RCT.

Nikodem 1993

This is an RCT for preventing breast engorgement.

Phillips 1975

This is an RCT for preventing breast engorgement.

Roberts 1995

This is an RCT for treating breast engorgement.

Roberts 1998

This is an RCT for treating breast engorgement.

Schurz 1978

This is a quasi‐randomised trial (women were allocated by the first letter of their surname).

Swift 2003

This is an RCT of lactation suppression (breast binding).

Thomsen 1984

Treatment of mastitis, not prevention.

Waldenstrom 1994

This trial did not evaluate interventions for preventing mastitis ‐ it is an RCT comparing birth centre care versus usual obstetric care.

Characteristics of studies awaiting assessment [ordered by study ID]

Gensch 2006

Methods

Randomised controlled trial.

Participants

45 lactating mothers.

Interventions

Lanolin cream versus breast milk.

Outcomes

Mastitis observed in breast milk group.

Notes

Author has been contacted with regards this study. It is currently with a review committee and is not available. We will reassess this study at a later date

Data and analyses

Open in table viewer
Comparison 1. Antibiotic versus no antibiotic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Antibiotic versus no antibiotic, Outcome 1 Mastitis.

Comparison 1 Antibiotic versus no antibiotic, Outcome 1 Mastitis.

1.1 Antibiotic versus no antibiotic

3

471

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.11, 1.61]

1.2 Antibiotic versus placebo

2

387

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.15, 6.68]

1.3 Antibiotic versus mupirocin

1

44

Risk Ratio (M‐H, Fixed, 95% CI)

0.44 [0.05, 3.89]

1.4 Antibiotic versus fusidic acid

1

36

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.03, 1.81]

1.5 Antibiotic versus breastfeeding advice

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

0.17 [0.02, 1.28]

Open in table viewer
Comparison 2. Breastfeeding education (specialist) versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.1

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 1 Mastitis.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 1 Mastitis.

1.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

3.75 [0.35, 40.70]

1.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.17, 4.95]

2 Sore nipples Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.2

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 2 Sore nipples.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 2 Sore nipples.

2.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.72, 1.36]

2.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.66, 1.22]

2.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.36, 2.37]

3 Breast engorgement Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.3

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 3 Breast engorgement.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 3 Breast engorgement.

3.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.61 [0.03, 14.87]

3.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.71, 1.53]

3.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.73, 1.49]

4 Exclusive breastfeeding Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 2.4

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 4 Exclusive breastfeeding.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 4 Exclusive breastfeeding.

4.1 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.90, 1.18]

4.2 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.68, 1.14]

5 Breastfeeding problems, mean per mother Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

Analysis 2.5

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 5 Breastfeeding problems, mean per mother.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 5 Breastfeeding problems, mean per mother.

5.1 at hospital discharge

1

211

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.27, 0.67]

5.2 at 30 days

1

211

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.61, 0.21]

Open in table viewer
Comparison 3. Anti‐secretory factor in cereal versus standard cereal

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.24 [0.03, 1.72]

Analysis 3.1

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 1 Mastitis.

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 1 Mastitis.

2 Mastitis recurrence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 3.2

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 2 Mastitis recurrence.

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 2 Mastitis recurrence.

2.1 First recurrence

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 3.51]

2.2 Second recurrence

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.02, 10.45]

Open in table viewer
Comparison 4. Mupirocin ointment versus breastfeeding advice alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.39 [0.12, 1.35]

Analysis 4.1

Comparison 4 Mupirocin ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Comparison 4 Mupirocin ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Open in table viewer
Comparison 5. Fusidic acid ointment versus breastfeeding advice alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.27, 2.22]

Analysis 5.1

Comparison 5 Fusidic acid ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Comparison 5 Fusidic acid ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Open in table viewer
Comparison 6. Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.13, 2.00]

Analysis 6.1

Comparison 6 Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice, Outcome 1 Mastitis.

Comparison 6 Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice, Outcome 1 Mastitis.

Summary of quality assessment of included studies. Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Summary of quality assessment of included studies. Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Comparison 1 Antibiotic versus no antibiotic, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 1.1

Comparison 1 Antibiotic versus no antibiotic, Outcome 1 Mastitis.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 2.1

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 1 Mastitis.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 2 Sore nipples.
Figuras y tablas -
Analysis 2.2

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 2 Sore nipples.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 3 Breast engorgement.
Figuras y tablas -
Analysis 2.3

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 3 Breast engorgement.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 4 Exclusive breastfeeding.
Figuras y tablas -
Analysis 2.4

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 4 Exclusive breastfeeding.

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 5 Breastfeeding problems, mean per mother.
Figuras y tablas -
Analysis 2.5

Comparison 2 Breastfeeding education (specialist) versus usual care, Outcome 5 Breastfeeding problems, mean per mother.

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 3.1

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 1 Mastitis.

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 2 Mastitis recurrence.
Figuras y tablas -
Analysis 3.2

Comparison 3 Anti‐secretory factor in cereal versus standard cereal, Outcome 2 Mastitis recurrence.

Comparison 4 Mupirocin ointment versus breastfeeding advice alone, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 4.1

Comparison 4 Mupirocin ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Comparison 5 Fusidic acid ointment versus breastfeeding advice alone, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 5.1

Comparison 5 Fusidic acid ointment versus breastfeeding advice alone, Outcome 1 Mastitis.

Comparison 6 Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice, Outcome 1 Mastitis.
Figuras y tablas -
Analysis 6.1

Comparison 6 Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice, Outcome 1 Mastitis.

Comparison 1. Antibiotic versus no antibiotic

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Antibiotic versus no antibiotic

3

471

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.11, 1.61]

1.2 Antibiotic versus placebo

2

387

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.15, 6.68]

1.3 Antibiotic versus mupirocin

1

44

Risk Ratio (M‐H, Fixed, 95% CI)

0.44 [0.05, 3.89]

1.4 Antibiotic versus fusidic acid

1

36

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.03, 1.81]

1.5 Antibiotic versus breastfeeding advice

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

0.17 [0.02, 1.28]

Figuras y tablas -
Comparison 1. Antibiotic versus no antibiotic
Comparison 2. Breastfeeding education (specialist) versus usual care

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

3.75 [0.35, 40.70]

1.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.17, 4.95]

2 Sore nipples Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.72, 1.36]

2.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.66, 1.22]

2.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.93 [0.36, 2.37]

3 Breast engorgement Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 at hospital discharge

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.61 [0.03, 14.87]

3.2 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.71, 1.53]

3.3 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.73, 1.49]

4 Exclusive breastfeeding Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 at 7 days

1

210

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.90, 1.18]

4.2 at 30 days

1

203

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.68, 1.14]

5 Breastfeeding problems, mean per mother Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

5.1 at hospital discharge

1

211

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.27, 0.67]

5.2 at 30 days

1

211

Mean Difference (IV, Fixed, 95% CI)

‐0.20 [‐0.61, 0.21]

Figuras y tablas -
Comparison 2. Breastfeeding education (specialist) versus usual care
Comparison 3. Anti‐secretory factor in cereal versus standard cereal

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.24 [0.03, 1.72]

2 Mastitis recurrence Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 First recurrence

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 3.51]

2.2 Second recurrence

1

29

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.02, 10.45]

Figuras y tablas -
Comparison 3. Anti‐secretory factor in cereal versus standard cereal
Comparison 4. Mupirocin ointment versus breastfeeding advice alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

48

Risk Ratio (M‐H, Fixed, 95% CI)

0.39 [0.12, 1.35]

Figuras y tablas -
Comparison 4. Mupirocin ointment versus breastfeeding advice alone
Comparison 5. Fusidic acid ointment versus breastfeeding advice alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

40

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.27, 2.22]

Figuras y tablas -
Comparison 5. Fusidic acid ointment versus breastfeeding advice alone
Comparison 6. Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mastitis Show forest plot

1

42

Risk Ratio (M‐H, Fixed, 95% CI)

0.51 [0.13, 2.00]

Figuras y tablas -
Comparison 6. Mupirocin ointment+BF advice versus fusidic acid ointment+BF advice