A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling

Breastfeeding Clinical Trial

Official title:

A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling Strategies for Improving Breastfeeding Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270920
• Other study ID #: NUS IRB 03003
• Secondary ID: NHG RPR 03002
• Status: Completed
• Phase: N/A
• First received: December 28, 2005
• Last updated: July 10, 2008
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: July 2008
• 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 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.

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 The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Lactation counseling

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 (2)

Haider R, Ashworth A, Kabir I, Huttly SR. Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial [see commments]. Lancet. 2000 Nov 11;356(9242):1643-7. — View Citation

Morrow AL, Guerrero ML, Shults J, Calva JJ, Lutter C, Bravo J, Ruiz-Palacios G, Morrow RC, Butterfoss FD. Efficacy of home-based peer counselling to promote exclusive breastfeeding: a randomised controlled trial. Lancet. 1999 Apr 10;353(9160):1226-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
Secondary	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.