NCT00270192

Brief Summary

This randomized controlled trial addresses the impact of simple antenatal breastfeeding educational interventions on breastfeeding rates and practice in a tertiary hospital setting. Hypothesis: A single antenatal encounter, which includes breastfeeding educational material and individual instruction with a lactation counselor, can improve the initiation, duration and exclusivity of breastfeeding compared to routine antenatal care or the use of educational material alone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

October 24, 2006

Status Verified

December 1, 2005

First QC Date

December 23, 2005

Last Update Submit

October 23, 2006

Conditions

Breastfeeding

Keywords

Breastfeedingexclusiveeducationcounseling

Outcome Measures

Primary Outcomes (1)

  • Comparison of exclusive or predominant breastfeeding rates in intervention groups versus controls

Secondary Outcomes (1)

  • Breastfeeding initiation, defined as any breastfeeding type within the first 2 weeks of delivery

Interventions

individual lactation counseling and educational materialBEHAVIORAL
educational material aloneBEHAVIORAL
routine antenatal care without educational interventionBEHAVIORAL

Eligibility Criteria

Age21 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancy
  • gestation of at least 36 weeks at recruitment
  • no uterine scar
  • the absence of any obstetric complication that would contraindicate vaginal delivery.

You may not qualify if:

  • refusal to participate in trial
  • contraindications to labour, vaginal delivery, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (1)

  • Foo LL, Quek SJ, Ng SA, Lim MT, Deurenberg-Yap M. Breastfeeding prevalence and practices among Singaporean Chinese, Malay and Indian mothers. Health Promot Int. 2005 Sep;20(3):229-37. doi: 10.1093/heapro/dai002. Epub 2005 Apr 6.

    PMID: 15814526BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yah Shih Chan, MHSc

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

  • Citra N Mattar, MRANZCOG

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 26, 2005

Study Start

May 1, 2002

Study Completion

December 1, 2004

Last Updated

October 24, 2006

Record last verified: 2005-12

Locations

SG(1)