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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN89131885
Date of registration: 07/07/2005
Prospective Registration: No
Primary sponsor: University of Birmingham (UK)
Public title: An evaluation of the relative effectiveness of interventions based on the transtheoretical model (TTM) of behaviour change (stages of change) compared with standard care in helping women to stop smoking in pregnancy
Scientific title:
Date of first enrolment: 01/03/1999
Target sample size: 918
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN89131885
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Paul    Aveyard
Address:  Department of Primary Care & General Practice University of Birmingham B15 2TT Birmingham United Kingdom
Telephone: +44 (0)121 414 8529
Email: p.n.aveyard@bham.ac.uk
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Pregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English.
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Female
Health Condition(s) or Problem(s) studied
Smoking in pregnancy
Pregnancy and Childbirth
Smoking in pregnancy
Intervention(s)
A cluster randomized trial of three interventions:
1. Standard care
2. Self-help manual and enhanced stage-based counselling
3. Self-help manual, enhanced stage-based counselling and use of an interactive computer program
Primary Outcome(s)
Biochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy.
Secondary Outcome(s)
Point prevalence abstinence, self-reported abstinence.
Secondary ID(s)
MREC 99/7/50
Source(s) of Monetary Support
West Midlands Health Authorities (UK)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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