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Completed

NCT Number: NCT00270920

A Randomised Controlled Trial to Compare Antenatal Preparation and Postnatal Counseling

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

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 The mothers who are not contactable for 3 consecutive months will be withdrawn from the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Lactation counseling

Behavioral

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Dec 29, 2005
Registry last updated
Jul 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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