Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001305617
Ethics application status
Approved
Date submitted
10/09/2014
Date registered
15/12/2014
Date last updated
15/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Breastfeeding Self-Care Program on Breastfeeding Self-Efficacy among Primiparous women
Scientific title
Effects of a Breastfeeding Self-Care Program on Breastfeeding Self-Efficacy among Primiparous women.
Secondary ID [1] 285301 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 292982 0
Condition category
Condition code
Reproductive Health and Childbirth 293274 293274 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Breastfeeding Self-Care Program (BSC-P) was given to primiparous women for one hour by primary researcher who was a nurse educator with midwifery qualification. The program included a booklet and a 14-minutes compact disk (CD) which focused on information about breastfeeding, for example; how to position and latch-on the baby, and how to identify if the baby was feeding well. We used the standard booklet from the Malaysian Ministry of Health together with breastfeeding self-checklist. The 14-item checklist was extracted from Clinical guidelines for the establishment of exclusive breastfeeding (International Board of Certified Lactation Consultant, 2005).
Two individualized sessions at the woman’s bedside in the postnatal ward was provided during early postpartum period. The first session was carried out soon after group allocation within 24 hours of delivery. The second session was within 24 hours of the first session. One week after hospital discharge, the woman was contacted via telephone for the third session. The primary researcher observed and assessed breastfeeding using the Breastfeed Observation Aid from UNICEF/WHO (2006), which consists of five components: a) general condition of the woman and baby, b) breast, c) baby’s position, d) baby’s attachment, and e) suckling. The participants were also reminded to read program booklet and watch the CD that would help to overcome the difficulties in breastfeeding.
Intervention code [1] 290210 0
Other interventions
Comparator / control treatment
Primiparous women in control group received only standard postnatal care where they were given routine health teaching by nurses or midwives without supplementary reading resources.
Control group
Active

Outcomes
Primary outcome [1] 293113 0
breastfeeding self-efficacy scores using BSES-SF
Timepoint [1] 293113 0
Baseline and 6 weeks post commencement of the intervention.
Secondary outcome [1] 311706 0
association of maternal demographic variables (age, race, education, work status and others) with BSES-SF scores
Timepoint [1] 311706 0
6 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
1) first time delivery
2) singleton birth
3) delivered full term infant at or after 37 weeks of gestation
4) initiated breastfeeding, and
5) able to speak and understand English or Malay.
Minimum age
18 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The primiparous women having a condition that might interfere with breastfeeding were excluded; such conditions were women with psychosis or severe illness after delivery, antibiotic therapy that required pumping and discarding, infants with congenital anomaly and infants in NICU for more than 24 hours.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
362 primiparous women admitted to postnatal ward of the hospital were assessed for eligibility during the study period from December 2011 to February 2012. The women who meet the inclusion criteria were briefly introduced to the study by the primary researcher and asked for the permission to provide detailed explanation about the study purposes and procedure. Women who deliver vaginally were approached 6-12 hours after delivery and those with a cesarean delivery were approached at 12-18 hours post-delivery. Participants were assigned into intervention group and control group by alternate week. Women admitted in first week and third week were assigned in the intervention group and those admitted in second and fourth week were assigned in the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size was calculated using the formula by Sakpal.20 The mean difference 5.1 with standard deviation of 10.92 (SE=1.5, n=53) was calculated based on the results of previous studies by McQueen, Dennis, Stremler, & Norman (2011). In order to reduce the risk of committing type II error due to insufficient sample size and statistical power, the researcher fixed the power at 0.80 and alpha value of 0.05. To anticipate the potential attritions of subjects during the course of study, additional 10% of the samples were recruited. The total sample size was 90, with 45 in each group.
To compare categorical variables between the intervention and the control group, Chi-square test was used. Since the data for breastfeeding efficacy score was not normally distributed, the Wilcoxon Signed-Rank test was used to compare the score before and after intervention. To identify association between BSES score and intended duration of breastfeeding, the Spearman’s Correlation Coefficient statistical test was used. A two-tailed level of statistical significance of 0.05 was used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/12/2011
Actual
5/12/2011
Date of last participant enrolment
Anticipated
29/02/2012
Actual
29/02/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 6342 0
Malaysia
State/province [1] 6342 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 289921 0
University
Name [1] 289921 0
University of Malaya Postgraduate Research Fund
Country [1] 289921 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 288611 0
None
Name [1] 288611 0
Address [1] 288611 0
Country [1] 288611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291639 0
Medical Ethic Comittee, University Malaya Medical Centre
Ethics committee address [1] 291639 0
Ethics committee country [1] 291639 0
Malaysia
Date submitted for ethics approval [1] 291639 0
03/11/2011
Approval date [1] 291639 0
23/11/2011
Ethics approval number [1] 291639 0

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

Contacts
Principal investigator
Name 51290 0
Ms Jagjit Kaur Najar Singh
Address 51290 0
a)Department of Nursing, Faculty of Medicine & Health Sciences, University Tunku Abdul Rahman, 43000 Kajang, Selangor, Malaysia
b) Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia
Country 51290 0
Malaysia
Phone 51290 0
+60163176468
Fax 51290 0
Email 51290 0
[email protected]
Contact person for public queries
Name 51291 0
Jagjit Kaur Najar Singh
Address 51291 0
a)Department of Nursing, Faculty of Medicine & Health Sciences, University Tunku Abdul Rahman, 43000 Kajang, Selangor, Malaysia
b) Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia
Country 51291 0
Malaysia
Phone 51291 0
+60163176468
Fax 51291 0
Email 51291 0
[email protected]
Contact person for scientific queries
Name 51292 0
Chong Mei Chan
Address 51292 0
Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia
Country 51292 0
Malaysia
Phone 51292 0
+60379493675
Fax 51292 0
Email 51292 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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