NCT01893736

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
722

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

June 6, 2013

Last Update Submit

March 12, 2015

Conditions

Keywords

Breastfeedingprofessional supportpostnatalinterventionsexclusive breastfeedingrandomized controlled trial

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 INTERVENTION

In-hospital usual care consists of routine intrapartum and postnatal obstetric care. No extra intervention will be provided by research team.

In-hospital professional support

EXPERIMENTAL

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

Postpartum telephone follow-up support

EXPERIMENTAL

Participants in "postpartum telephone follow-up support" arm will receive telephone support in the first 4 weeks postpartum.

Other: Postpartum telephone follow-up support

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.

In-hospital professional 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.

Postpartum telephone follow-up support

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Marie Tarrant, PhD, MPH, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

Locations