Professional Breastfeeding Support Intervention
A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding
1 other identifier
interventional
722
1 country
4
Brief Summary
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2010
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedMarch 17, 2015
March 1, 2015
1.6 years
June 6, 2013
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
1 month postpartum
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
2 months postpartum
Prevalence of any and exclusive breastfeeding
Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum
3 months postpartum
Secondary Outcomes (1)
Median duration of breastfeeding
6 month postpartum
Study Arms (3)
Control
NO INTERVENTIONIn-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.
In-hospital professional support
EXPERIMENTALThe participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization.
Postpartum telephone follow-up support
EXPERIMENTALParticipants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.
Interventions
In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.
Eligibility Criteria
You may qualify if:
- delivers at participating trial site,
- primiparous,
- intends to breastfeed,
- years of age or older,
- has singleton pregnancy,
- Cantonese speaking,
- Hong Kong resident for more than one year,
- no serious medical or obstetrical complications
You may not qualify if:
- \< 37 weeks gestation,
- an Apgar score \< 8 at five minutes,
- a birth weight \< 2500 grams,
- born with any severe medical conditions or congenital malformations,
- is placed in the special care nursery for more than 48 hours after delivery,
- is placed in the intensive care nursery after delivery,
- not entitled to health benefits in Hong Kong (NEP).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kwong Wah Hospital
Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Related Publications (1)
Fu IC, Fong DY, Heys M, Lee IL, Sham A, Tarrant M. Professional breastfeeding support for first-time mothers: a multicentre cluster randomised controlled trial. BJOG. 2014 Dec;121(13):1673-83. doi: 10.1111/1471-0528.12884. Epub 2014 May 26.
PMID: 24861802RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Tarrant, PhD, MPH, RN
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 6, 2013
First Posted
July 9, 2013
Study Start
September 1, 2010
Primary Completion
April 1, 2012
Study Completion
March 1, 2013
Last Updated
March 17, 2015
Record last verified: 2015-03