Professional Breastfeeding Support Intervention

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Breastfeeding	Other: In-hospital professional support; Other: Postpartum telephone follow-up support	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	722 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	March 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Prevalence of any and exclusive breastfeeding [ Time Frame: 1 month postpartum ]
   Any breastfeeding rate and exclusive breastfeeding rate at 1 month postpartum
2. Prevalence of any and exclusive breastfeeding [ Time Frame: 2 months postpartum ]
   Any breastfeeding rate and exclusive breastfeeding rate at 2 months postpartum
3. 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 :

1. Median duration of breastfeeding [ Time Frame: 6 month postpartum ]
   The median duration of any breastfeeding and the median duration of exclusive breastfeeding.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	Marie Tarrant, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT01893736 History of Changes
Other Study ID Numbers:	PBFS-1
First Posted:	July 9, 2013
Last Update Posted:	March 17, 2015
Last Verified:	March 2015

Keywords provided by Marie Tarrant, The University of Hong Kong:

Breastfeeding; professional support; postnatal	interventions; exclusive breastfeeding; randomized controlled trial