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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614001305617
Date of registration: 15/12/2014
Prospective Registration: No
Primary sponsor: University of Malaya
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.
Date of first enrolment: 05/12/2011
Target sample size: 90
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614001305617.aspx
Study type:  Interventional
Study design:  Purpose: Educational / counselling / training; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;  
Phase:  Not Applicable
Countries of recruitment
Malaysia
Contacts
Name: Dr Chong Mei Chan   
Address:  Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia Malaysia
Telephone: +60379493675
Email: mcchong@um.edu.my
Affiliation: 
Name: Ms Jagjit Kaur Najar Singh   
Address:  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 Malaysia
Telephone: +60163176468
Email: jagjitk@utar.edu.my
Affiliation: 
Key inclusion & exclusion criteria
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.

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.

Age minimum: 18 Years
Age maximum: 41 Years
Gender: Females
Health Condition(s) or Problem(s) studied
Reproductive Health and Childbirth - Breast feeding
Breastfeeding ;
Breastfeeding
Intervention(s)
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.
Primary Outcome(s)
breastfeeding self-efficacy scores using BSES-SF [Baseline and 6 weeks post commencement of the intervention.]
Secondary Outcome(s)
association of maternal demographic variables (age, race, education, work status and others) with BSES-SF scores[6 weeks post commencement of the intervention]
Secondary ID(s)
NIL
Source(s) of Monetary Support
University of Malaya Postgraduate Research Fund
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Medical Ethic Comittee, University Malaya Medical Centre
Results
Results available:
Date Posted:
Date Completed:
URL:
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