Condition category
Pregnancy and Childbirth
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Graffy

ORCID ID

Contact details

Department of General Practice and Primary Care
Queen Mary and Westfield College
Mile End
London
E1 4NS
United Kingdom
+44 (0)20 7882 7702/7923 4122

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC00941

Study information

Scientific title

Acronym

Study hypothesis

This proposal is for randomised controlled trial to test whether women who receive extra support from a breastfeeding counsellor breastfeed for longer than those who do not. Women having their first child or women who did not breastfeed their last child for more than six weeks will be randomly allocated to determine whether or not they receive additional support from a breastfeeding counsellor. The study will be performed in general practice and women will be recruited and followed up by members of their primary care team.
This project addresses the question of how we can help women who have difficulties with breastfeeding and improve breastfeeding rates nationally. It builds up on the applicants previous research and will be a value to many mothers. If this study shows that breastfeeding counsellors are effective, it would encourage more women to train as counsellors and suggest that the NHS should promote their work.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Breastfeeding

Intervention

1. Support from a breastfeeding counsellor
2. Standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of women breast-feeding to 4 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/1997

Overall trial end date

01/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Women attending for antenatal care between 28 and 36 weeks of pregnancy are asked to complete the initial questionnaire, to determine if they are eligible for inclusion. Mothers were eligible for inclusion if they were considering breast feeding, not having breast-fed a previous child for more than 6 weeks

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

32 practices, 720 women (added 07/01/10)

Participant exclusion criteria

1. No spoken English
2. Unsafe for a volunteer to visit the woman's home

Recruitment start date

01/12/1997

Recruitment end date

01/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Practice and Primary Care
London
E1 4NS
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14703543

Publication citations

  1. Results

    Graffy J, Taylor J, Williams A, Eldridge S, Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding., BMJ, 2004, 328, 7430, 26, doi: 10.1136/bmj.328.7430.26.

Additional files

Editorial Notes