A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling
July 10, 2008 updated by: National University Hospital, Singapore
A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling Strategies for Improving Breastfeeding Rates
This is a randomised controlled trial to compare antenatal preparation and postnatal counseling strategies for improving breastfeeding rates.
The objectives are:
- to study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeediing in mothers
- 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.
Study Overview
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The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.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 Type
Interventional
Enrollment
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 119074
- National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Study the effect of a standard two-encounter postnatal lactation counseling protocol on the initiation and maintenance of exclusive breastfeeding in mothers
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mary Rauff, MBBS, FRCOG, National University of Singapore /National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1016/S0140-6736(98)08037-4.
- 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. doi: 10.1016/s0140-6736(00)03159-7.
- Su LL, Chong YS, Chan YH, Chan YS, Fok D, Tun KT, Ng FS, Rauff M. Antenatal education and postnatal support strategies for improving rates of exclusive breast feeding: randomised controlled trial. BMJ. 2007 Sep 22;335(7620):596. doi: 10.1136/bmj.39279.656343.55. Epub 2007 Aug 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
December 28, 2005
First Submitted That Met QC Criteria
December 28, 2005
First Posted (Estimate)
December 29, 2005
Study Record Updates
Last Update Posted (Estimate)
July 15, 2008
Last Update Submitted That Met QC Criteria
July 10, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- NUS IRB 03003
- NHG RPR 03002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.