Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000438459
Ethics application status
Approved
Date submitted
24/08/2007
Date registered
29/08/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-Management versus Usual Care of Mastitis Following Childbirth: A Randomised Control Trial
Scientific title
Self-Management versus Usual Care of Mastitis Following Childbirth: A Randomised Control Trial to measure the prevalence of mastitis in breastfeeding women following childbirth
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mastitis in mothers following childbirth 2294 0
Condition category
Condition code
Reproductive Health and Childbirth 2391 2391 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-Management of mastitis use of an educational flow chart for the period of six months following recruitment into the study
Intervention code [1] 2008 0
Prevention
Comparator / control treatment
Usual care of mastitis postnataly, involves the identifying that a mother has mastitis usually by her General Practioner (GP) or other health care professinal. The mother would than follow treatment as recommended.
Control group
Active

Outcomes
Primary outcome [1] 3291 0
Measure the prevalence of mastitis in breastfeeding women following childbirth
Timepoint [1] 3291 0
six months after randomisation
Secondary outcome [1] 5477 0
Measure breastfeeding confidence, exclusivity and duration in breastfeeding women following child birth
Timepoint [1] 5477 0
Six months after randomisation
Secondary outcome [2] 5478 0
Measure General Practioner (GP) visits of breastfeeding women following childbirth that develop mastitis with or without the use of the educational self-management interventin tool
Timepoint [2] 5478 0
six months after childbirth

Eligibility
Key inclusion criteria
Breastfeeding women aged 18 years and over that give birth at the Gold Coast Hospital
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women who don’t have access to a phone
women that are non-English speaking
women with babies in special care nursery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Breastfeeding women will be recruited from the Gold Coast hospital following the birth of their child. Recruited subjects will be:
1.Randomised (using a randomised table of numbers).
2.Randomisation will be done by a third party at Bond University.
3.Sealed opaque envelopes will be used to conceal the intervention.
4.Allocation concealment will be achieved by the principal investigator when recruiting participants being blinded to which intervention the subject is allocated. to achieve this a random selection of concealed opaque envelope (containing intervention details) will be used. This will take place when participants are recruited into the study.
5.Both the principal investigator and the participants will be blinded to treatment allocation.
6.The allocation schedule will be kept on a disc and locked in a secure filing cabinet.
7.The principal investigator, the participants and the statistician will be blinded to the intervention allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants that are breastfeeding will be recruited from the Gold Coast Hospital after childbirth. Recruited subjects will be randomised using a randomised table of numbers. The randomising process will be done by a third party so that the principal investigators and subjects will be blinded to their treatment allocation. Participants will be given a plan envelop with either the intervention or comparator information in it.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 234 0
4215

Funding & Sponsors
Funding source category [1] 2549 0
University
Name [1] 2549 0
Bond University
Country [1] 2549 0
Australia
Primary sponsor type
University
Name
Bond University
Address
PHCRED Faculty of Health Science & Medicine
Bond University
Gold Coast QLD
Country
Australia
Secondary sponsor category [1] 2308 0
Hospital
Name [1] 2308 0
Gold Coast Health Service
Address [1] 2308 0
Gold Coast Health Service
108 Nerang st
Southport Gold Coast
QLD 4215
Country [1] 2308 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4475 0
Ethics committee address [1] 4475 0
Ethics committee country [1] 4475 0
Date submitted for ethics approval [1] 4475 0
22/08/2007
Approval date [1] 4475 0
Ethics approval number [1] 4475 0
R0606

Summary
Brief summary
Developing recurring mastitis is an area of research where there is little published work. Studying mastitis management after childbirth may lead to improved understanding of the outcomes for breastfeeding duration. We therefore wish to conduct a Randomised Control Trial (RCT) that will examine the outcomes of ‘Self-Management’ of mastitis versus ‘Usual Care’ in breastfeeding women following childbirth.
The study intends to: Measure the prevalence of mastitis in a population of breastfeeding women. Measure breastfeeding duration and exclusivity in a population of breastfeeding women. Trial the ‘Self-Management’ of mastitis intervention. Measure women’s beastfeeding confidence.
Hypotheses
Self management of mastitis lowers the rate of GP visits
Self management of mastitis increase breastfeeding confidence
Self management of mastitis increase breastfeeding duration
Self management of mastitis increase breastfeeding exclusivity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28004 0
Address 28004 0
Country 28004 0
Phone 28004 0
Fax 28004 0
Email 28004 0
Contact person for public queries
Name 11161 0
Mrs Maree Crepinsek
Address 11161 0
PHCRED Health Science & Medicine
Bond University
Gold Coast QLD 4229
Country 11161 0
Australia
Phone 11161 0
+61 7 5595 4494
Fax 11161 0
+61 7 5595 4122
Email 11161 0
[email protected]
Contact person for scientific queries
Name 2089 0
Dr Neil Smart
Address 2089 0
PHCRED Health Science & Medicine
Bond University
Gold Coast QLD 4229
Country 2089 0
Australia
Phone 2089 0
+61 7 5595 4453
Fax 2089 0
+61 7 5595 4122
Email 2089 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.