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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

Tracking Information
First Submitted Date  ICMJE July 18, 2012
First Posted Date  ICMJE July 24, 2012
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
Exclusive Breastfeeding Rate [ Time Frame: 6 weeks postpartum ]
Exclusive breastfeeding rate at 6 weeks postpartum
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2012)
  • Median Duration of Breastfeeding [ Time Frame: 6 months postpartum ]
    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 ]
    Rate of Exclusive Breastfeeding at 3 Months and 6 Months Postpartum
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
Official Title  ICMJE A Randomized Controlled Trial of an Antenatal Intervention to Increase Exclusive Breastfeeding
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breastfeeding
  • Pregnancy
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Antenatal Breastfeeding Intervention
Publications * Wong KL, Fong DY, Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-8. doi: 10.1097/AOG.0000000000000481.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2014)
472
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2012)
300
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01648114
Other Study ID Numbers  ICMJE ABFS-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie Tarrant, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Tarrant, PhD, MPH, RN The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP