NCT01648114

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
472

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

July 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

July 18, 2012

Last Update Submit

March 12, 2015

Conditions

BreastfeedingPregnancy

Keywords

breastfeedingpregnancyantenatalexclusive breastfeedingeducation

Outcome Measures

Primary Outcomes (1)

  • Exclusive Breastfeeding Rate

    Exclusive breastfeeding rate at 6 weeks postpartum

    6 weeks postpartum

Secondary Outcomes (2)

  • Median Duration of Breastfeeding

    6 months postpartum

  • Exclusive Breastfeeding Rate at 3 Months and 6 Months Postpartum

    6 Months Postpartum

Study Arms (2)

Control

NO INTERVENTION

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.

Antenatal Breastfeeding Intervention

EXPERIMENTAL

Antenatal intervention group will receive usual care plus a 20 to 30-minute one-to-one educational intervention about breastfeeding.

Other: Antenatal Breastfeeding Intervention

Interventions

Antenatal Breastfeeding InterventionOTHER

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

Antenatal Breastfeeding Intervention

Eligibility Criteria

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

You may qualify if:

  • singleton pregnancy,
  • primiparous
  • years of age or older,
  • at least 36 weeks of gestation,
  • Cantonese speaking,
  • Hong Kong resident,
  • no serious medical or obstetrical complications,
  • staying in Hong Kong for at least 6 months after delivery, and
  • intention to breastfeed.

You may not qualify if:

  • Participants will be excluded from the study if they are not entitled to health benefits in Hong Kong (NEP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tsan Yuk Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Wong KL, Tak Fong DY, Yin Lee IL, Chu S, Tarrant M. Antenatal education to increase exclusive breastfeeding: a randomized controlled trial. Obstet Gynecol. 2014 Nov;124(5):961-968. doi: 10.1097/AOG.0000000000000481.

    PMID: 25437725RESULT

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

July 18, 2012

First Posted

July 24, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2013

Study Completion

February 1, 2014

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

HK(3)