Condition category
Pregnancy and Childbirth
Date applied
05/07/2005
Date assigned
07/07/2005
Last edited
04/01/2008
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 Paul Aveyard

ORCID ID

Contact details

Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8529
p.n.aveyard@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MREC 99/7/50

Study information

Scientific title

Acronym

Study hypothesis

That interventions based on the TTM would help more pregnant smokers stop smoking than standard care.

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

GP practices

Trial type

Treatment

Patient information sheet

Condition

Smoking in pregnancy

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Biochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy.

Secondary outcome measures

Point prevalence abstinence, self-reported abstinence.

Overall trial start date

01/03/1999

Overall trial end date

31/03/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

918

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/1999

Recruitment end date

31/03/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

West Midlands Health Authorities (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

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16053527

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16643698

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15749141

18-month postpartum follow-up:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15598198

Cohort results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12930219

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12773727

Publication citations

  1. Results

    Aveyard P, Lawrence T, Evans O, Cheng KK, The influence of in-pregnancy smoking cessation programmes on partner quitting and women's social support mobilization: a randomized controlled trial [ISRCTN89131885]., BMC Public Health, 2005, 5, 80, doi: 10.1186/1471-2458-5-80.

  2. Results

    Aveyard P, Lawrence T, Cheng KK, Griffin C, Croghan E, Johnson C, A randomized controlled trial of smoking cessation for pregnant women to test the effect of a transtheoretical model-based intervention on movement in stage and interaction with baseline stage., Br J Health Psychol, 2006, 11, Pt 2, 263-278, doi: 10.1348/135910705X52534.

  3. Results

    Aveyard P, Lawrence T, Croghan E, Evans O, Cheng KK, Is advice to stop smoking from a midwife stressful for pregnant women who smoke? Data from a randomized controlled trial., Prev Med, 2005, 40, 5, 575-582, doi: 10.1016/j.ypmed.2004.07.012.

  4. Cohort results

    Lawrence T, Aveyard P, Croghan E, What happens to women's self-reported cigarette consumption and urinary cotinine levels in pregnancy?, Addiction, 2003, 98, 9, 1315-1320.

  5. Results

    Lawrence T, Aveyard P, Evans O, Cheng KK, A cluster randomised controlled trial of smoking cessation in pregnant women comparing interventions based on the transtheoretical (stages of change) model to standard care., Tob Control, 2003, 12, 2, 168-177.

  6. Lawrence T, Aveyard P, Cheng KK, Griffin C, Johnson C, Croghan E, Does stage-based smoking cessation advice in pregnancy result in long-term quitters? 18-month postpartum follow-up of a randomized controlled trial., Addiction, 2005, 100, 1, 107-116, doi: 10.1111/j.1360-0443.2005.00936.x.

Additional files

Editorial Notes