A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding (ABFS)

March 12, 2015 updated by: Marie Tarrant, The University of Hong Kong
The investigators will conduct an educational intervention for pregnant women who are planning to breastfeed to promote exclusive breastfeeding and to increase the duration of breastfeeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding.

Study Type

Interventional

Enrollment (Actual)

472

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

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Kwong Wah Hospital
      • Hong Kong, Hong Kong
        • Tsan Yuk Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. singleton pregnancy,
  2. primiparous
  3. 18 years of age or older,
  4. at least 36 weeks of gestation,
  5. Cantonese speaking,
  6. Hong Kong resident,
  7. no serious medical or obstetrical complications,
  8. staying in Hong Kong for at least 6 months after delivery, and
  9. intention to breastfeed.

Exclusion Criteria:

Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual outpatient antenatal care consists of routine checking of the maternal and foetal health by either clinic midwives or obstetricians along with health education to promote a healthy pregnancy.
Experimental: Antenatal Breastfeeding Intervention
Antenatal intervention group will receive usual care plus a 20 to 30-minute one-to-one educational intervention about breastfeeding.
Other: Antenatal Breastfeeding Intervention
The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding Rate
Time Frame: 6 weeks postpartum
Exclusive breastfeeding rate at 6 weeks postpartum
6 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Duration of Breastfeeding
Time Frame: 6 months postpartum
The median duration of exclusive breastfeeding and the median duration of any breastfeeding
6 months postpartum
Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum
Time Frame: 6 Months Postpartum
Rate of Exclusive Breastfeeding at 3 Months and 6 Months Postpartum
6 Months Postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Marie TARRANT, PhD, MPH, RN, The University of Hong Kong

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

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

August 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABFS-1

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.

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