ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01648114
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong

Brief Summary:
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 or disease Intervention/treatment Phase
Breastfeeding Pregnancy Other: Antenatal Breastfeeding Intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
Study Start Date : August 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Exclusive Breastfeeding Rate [ Time Frame: 6 weeks postpartum ]
    Exclusive breastfeeding rate at 6 weeks postpartum


Secondary Outcome Measures :
  1. Median Duration of Breastfeeding [ Time Frame: 6 months postpartum ]
    The median duration of exclusive breastfeeding and the median duration of any breastfeeding

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648114


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

Publications of Results:
Responsible Party: Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01648114     History of Changes
Other Study ID Numbers: ABFS-1
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

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