A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling

Not Applicable

Completed

• Conditions: Breastfeeding

• Registration Number: NCT00270920
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates.

The objectives are:

1. to study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeediing in mothers

2. to compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.

Detailed Description

All pregnant mothers who wish to breastfeed after 34 weeks of gestation, and who do not have a high risk pregnancy as determined by investigator or have a multiple pregnancy in current pregnancy and have given their written informed consent will be randomised into three groups. Group 1 will receive standard hospital care. Group 2 will receive 1 session of antenatal counseling and Group 3 will receive 2 sessions of postanatal lactation counseling. All will receive postnatal follow up phone calls using questions from Case Report Forms at 2 weeks, 8 weeks, 3 months, 6 months and 12 months. The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-12-28
• Study First Submitted QC: 2005-12-28
• Study First Posted: 2005-12-29
• Study Completion: 2006-03
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-10
• Last Update Posted: 2008-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

Pregnant woman who wants to breastfeed her child after 34 weeks of gestation and written informed consent given

Exclusion Criteria

Pregnant women with high risk pregnancy as determined by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers

Secondary Outcome Measures

Name	Time	Method
Compare the effect of a standard two-encounter postnatal lactation counseling protocol with a single-encounter antenatal breastfeeding education protocol on the initiation and maintenance of exclusive breastfeeding in mothers.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore