Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001014943
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
21/09/2011
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telephone lactation counseling and breast feeding practices: a randomized controlled trial
Scientific title
The effect of telephone lactation counseling versus conventional lactation support on breast feeding practice in mothers
Secondary ID [1] 263080 0
NMRR-09-414-4066, Malaysian National Medical Research Registry www.nmrr.gov.my
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding Practice at 6 month postpartum 270831 0
Condition category
Condition code
Public Health 271013 271013 0 0
Health promotion/education
Reproductive Health and Childbirth 271018 271018 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lactation counseling given to mothers by certified lactation counselors via telephone twice monthly to each lactating mother plus the current conventional care (thus it is expected that every mother will receive twelve lactation counselings at the end of the study). Contacts are discontinued at any time if mother decide to completely stop breast feeding. Mothers are allowed to receive the current conventional care (postnatal breast feeding promotion or support by own healthcare provider). The duration of each lactation counseling depends on each of the mothers' need. This intervention will be conducted for 6 months postpartum for every participant in the intervention group.

Lactation counselors in this study are the nursing staffs from Maternity Hospital Kuala Lumpur who are certified as lactation counselors (have undergone 40 hours lactation management and counseling course).
Intervention code [1] 269432 0
Behaviour
Comparator / control treatment
Mothers receiving current conventional care (postnatal breast feeding promotion or support by own healthcare provider).
Control group
Active

Outcomes
Primary outcome [1] 279673 0
breastfeeding practice using the "previous 24-hours" and the "ever given the infant anything besides breast milk since birth" definitions (WHO) i.e. exclusive breastfeeding, predominant breastfeeding, complementary breast feeding and stopped breastfeeding.
Timepoint [1] 279673 0
1, 4 & 6 month postpartum
Secondary outcome [1] 294170 0
number of telephone lactation counselings and the total hour of counseling received in the intervention group, and it will be compared to the duration of breast feeding and its relation to the breast feeding practice (i.e. exclusive, predominant, complementary and stopped breast feeding)
Timepoint [1] 294170 0
1, 4 & 6 month postpartum

Eligibility
Key inclusion criteria
Malaysian nationality, delivery at 37 weeks gestation or more, mothers who delivered only single infant, intending to breast feed; able to understand and communicate in spoken Malay Language or English; have received at least once any prenatal breastfeeding education programme; have telephone access and have given informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with multiple pregnancies or medical problems which may hinder breastfeeding, delivered via Caesarean section or whose baby subsequently required prolonged care in a Special Care Nursery

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3855 0
Malaysia
State/province [1] 3855 0

Funding & Sponsors
Funding source category [1] 269904 0
University
Name [1] 269904 0
Postgraduate Research Fund, Institute of Research Management and Consultancy, University Malaya
Country [1] 269904 0
Malaysia
Primary sponsor type
University
Name
Institute of Research Management and Consultancy (IPPP), University Malaya
Address
Institute of Research Management and Consultancy (IPPP)
University Malaya
50603 Kuala Lumpur
MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 268915 0
None
Name [1] 268915 0
Nil
Address [1] 268915 0
Nil
Country [1] 268915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271876 0
University Malaya Medical Centre (UMMC) Medical Ethics Committee
Ethics committee address [1] 271876 0
Ethics committee country [1] 271876 0
Date submitted for ethics approval [1] 271876 0
Approval date [1] 271876 0
Ethics approval number [1] 271876 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33188 0
Address 33188 0
Country 33188 0
Phone 33188 0
Fax 33188 0
Email 33188 0
Contact person for public queries
Name 16435 0
Dr Norzakiah Mohd Tahir
Address 16435 0
Department of Social & Preventive Medicine
Faculty of Medicine
University Malaya
50603 Kuala Lumpur
Malaysia
Country 16435 0
Malaysia
Phone 16435 0
+60196230311
Fax 16435 0
Email 16435 0
[email protected]
Contact person for scientific queries
Name 7363 0
Dr Norzakiah Mohd Tahir
Address 7363 0
Department of Social & Preventive Medicine
Faculty of Medicine
University Malaya
50603 Kuala Lumpur
Malaysia
Country 7363 0
Malaysia
Phone 7363 0
+60196230311
Fax 7363 0
Email 7363 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.