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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01648114
First received: July 18, 2012
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention
Breastfeeding
Pregnancy
 Other: Antenatal Breastfeeding Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Exclusive Breastfeeding Rate [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
    Exclusive breastfeeding rate at 6 weeks postpartum


Secondary Outcome Measures:
  • Median Duration of Breastfeeding [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    The median duration of exclusive breastfeeding and the median duration of any breastfeeding

  • Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum [ Time Frame: 6 Months Postpartum ] [ Designated as safety issue: No ]
    Rate of Exclusive Breastfeeding at 3 Months and 6 Months Postpartum


Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. singleton pregnancy,
  2. primaparous
  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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648114

Locations
Hong Kong
Tsan Yuk Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Marie Tarrant, PhD, MPH, RN The University of Hong Kong
  More Information

No publications provided

Responsible Party: Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01648114     History of Changes
Other Study ID Numbers: ABFS-1
Study First Received: July 18, 2012
Last Updated: June 5, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
breastfeeding
pregnancy
antenatal
exclusive breastfeeding
education

ClinicalTrials.gov processed this record on June 18, 2013