Condition category
Pregnancy and Childbirth
Date applied
09/12/2002
Date assigned
09/12/2002
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Judith Lumley

ORCID ID

Contact details

Director
Centre for the Study of Mothers' and Children's Health
La Trobe University
251 Faraday Street
Carlton
VIC 3053
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Research Ethics Number (La Trobe University): 00/124

Study information

Scientific title

Acronym

ROBIn (Reduction of Breast Infection) Trial

Study hypothesis

The aim of our study was to prevent mastitis in breastfeeding women with cracked nipples colonised with S. aureus. The hypothesis was that a course of antibiotics would reduce mastitis in breastfeeding women with cracked nipples colonized with S. aureus. Participating women were randomised to receive a seven-day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mastitis (prevention of) in lactating women

Intervention

Women with nipple swab positive for Staphylococcus aureus are randomised to receive a seven-day course of:
1. Flucloxacillin 500 mg qid, or
2. Identical placebo capsules

Intervention type

Drug

Phase

Not Applicable

Drug names

Flucloxacillin

Primary outcome measures

Incidence of mastitis in each group in the week following recruitment.

Secondary outcome measures

Nipple healing, nipple pain.

Overall trial start date

01/11/2001

Overall trial end date

30/11/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Breastfeeding women with at least one damaged nipple
2. English-speaking
3. Live in Melbourne
4. Not allergic to penicillin

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/11/2001

Recruitment end date

30/11/2002

Locations

Countries of recruitment

Australia

Trial participating centre

Director
Carlton
VIC 3053
Australia

Sponsor information

Organisation

La Trobe University (Australia)

Sponsor details

Faculty of Health Sciences
Melbourne
VIC 3086
Australia
+61 (0)3 9479 3583
lhs@latrobe.edu.au

Sponsor type

University/education

Website

http://www.latrobe.edu.au/health/healthsci_schoolcent.html

Funders

Funder type

Research council

Funder name

Medical Research Foundation for Women and Babies, Melbourne (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Australian National Health and Medical Research Council Public Health scholarship (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Antibiotics provided by CSL Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15369597

Publication citations

  1. Results

    Amir LH, Lumley J, Garland SM, A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389]., BMC Pregnancy Childbirth, 2004, 4, 1, 19, doi: 10.1186/1471-2393-4-19.

Additional files

Editorial Notes