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Professional Breastfeeding Support Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marie Tarrant, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01893736
First received: June 6, 2013
Last updated: March 12, 2015
Last verified: March 2015
History of Changes
  Purpose
The investigators will conduct an early postpartum professional breastfeeding intervention to postpartum women who are intended to breastfeed newborn babies to improve breastfeeding outcomes.

Condition Intervention
Breastfeeding
 Other: In-hospital professional support
Other: Postpartum telephone follow-up support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Professional Breastfeeding Support Intervention to Increase the Exclusivity and Duration of Breastfeeding

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Prevalence of any and exclusive breastfeeding [ Time Frame: 1 month postpartum ]
    Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum

  • Prevalence of any and exclusive breastfeeding [ Time Frame: 2 months postpartum ]
    Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum

  • Prevalence of any and exclusive breastfeeding [ Time Frame: 3 months postpartum ]
    Any breastfeeding rate and exclusive breastfeeding rate at 3 months postpartum


Secondary Outcome Measures:
  • Median duration of breastfeeding [ Time Frame: 6 month postpartum ]
    The median duration of any breastfeeding and the median duration of exclusive breastfeeding.
Enrollment: 722
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.
Experimental: In-hospital professional support
The participants in "in-hospital professional support" arm will receive three 30-minute one-to-one hands-on breastfeeding counseling sessions during postpartum hospitalization.
 Other: In-hospital professional support
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.
Experimental: Postpartum telephone follow-up support
Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.
 Other: Postpartum telephone follow-up support
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.

Detailed Description:

The aim of this study is to determine whether early post-partum professional breastfeeding support improves breastfeeding outcomes.

The primary hypotheses are:

  1. Exclusive breastfeeding rates at 1, 2, and 3 months will be increased among mother-infant pairs who receive professional lactation support or telephone follow-up support (intervention groups) when compared with those who receive usual post-natal breastfeeding support (control group);
  2. The rate of any breastfeeding (predominant or partial) at 1, 2, and 3 months will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;

The secondary hypotheses are:

  1. The overall duration of exclusive breastfeeding will be increased among mother-infant pairs in the intervention groups when compared with those in the control group;
  2. The overall duration of any breastfeeding (predominant or partial) will be increased among mother-infant pairs in the intervention groups when compared with those in the control group.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. delivers at participating trial site,
  2. primiparous,
  3. intends to breastfeed,
  4. 18 years of age or older,
  5. has singleton pregnancy,
  6. Cantonese speaking,
  7. Hong Kong resident for more than one year,
  8. no serious medical or obstetrical complications

Exclusion Criteria:

  1. < 37 weeks gestation,
  2. an Apgar score < 8 at five minutes,
  3. a birth weight < 2500 grams,
  4. born with any severe medical conditions or congenital malformations,
  5. is placed in the special care nursery for more than 48 hours after delivery,
  6. is placed in the intensive care nursery after delivery,
  7. not entitled to health benefits in Hong Kong (NEP).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893736

Locations
Hong Kong
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
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Marie Tarrant, PhD, MPH, RN The University of Hong Kong
  More Information

Publications:

Responsible Party: Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01893736     History of Changes
Other Study ID Numbers: PBFS-1
Study First Received: June 6, 2013
Last Updated: March 12, 2015

Keywords provided by Marie Tarrant, The University of Hong Kong:
Breastfeeding
professional support
postnatal
 interventions
exclusive breastfeeding
randomized controlled trial

ClinicalTrials.gov processed this record on May 25, 2017