Antenatal Educational Intervention for Improvement of Breastfeeding

Breastfeeding Clinical Trial

Official title:

The Effects Of Antenatal Breast Preparation On The Successful Initiation And Continuation Of Breastfeeding In Singaporean Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270192
• Other study ID #: NHG RPR 01101
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2005
• Last updated: October 23, 2006
• Start date: May 2002
• Est. completion date: December 2004

Study information

• Verified date: December 2005
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting.

Hypothesis: A single antenatal encounter, which includes breastfeeding educational material and individual instruction with a lactation counselor, can improve the initiation, duration and exclusivity of breastfeeding compared to routine antenatal care or the use of educational material alone

Description:

Breastfeeding rates in many developed countries, particularly in terms of exclusive and predominant breastfeeding, often fall short of the recommended practice advised by the World Health Organization and the American Academy of Pediatrics. Despite increasing awareness of the many advantages of breastfeeding the challenge remains to implement programs that can effectively improve short and long-term breastfeeding rates.

The Singapore National Breastfeeding Survey 2001 (Foo et al, 2005) demonstrated an encouraging breastfeeding initiation rate of 94.5%. However only 21.1% continued to breastfeed at 6 months with fewer than 5% breastfeeding exclusively.

The formal preparation of expectant mothers for breastfeeding is not part of routine antenatal care in many practices. We feel that it may prove beneficial especially in an environment with a low prevalence of breastfeeding. The aim of this trial is to demonstrate the impact of single-encounter antenatal education combining educational material with individual instruction, on breastfeeding initiation and duration and on infant feeding practice, compared with routine antenatal care and educational material alone in a tertiary hospital setting.

401 women are randomized into 3 predetermined groups and are exposed to specific antenatal education materials targeting breastfeeding techniques; the control group receives routine antenatal care. Data regarding breastfeeding rate, quality and duration is collected over a 1 year period.

Comparisons: breastfeeding initiation rate, duration and type among women receiving lactation counseling with educational material, educational material without individual counseling, and routine antenatal care without educational intervention

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• gestation of at least 36 weeks at recruitment

• no uterine scar

• the absence of any obstetric complication that would contraindicate vaginal delivery.

Exclusion Criteria:

• refusal to participate in trial

• contraindications to labour, vaginal delivery, breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• individual lactation counseling and educational material

• educational material alone

• routine antenatal care without educational intervention

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. Epub 2005 Apr 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of exclusive or predominant breastfeeding rates in intervention groups versus controls
Secondary	Breastfeeding initiation, defined as any breastfeeding type within the first 2 weeks of delivery