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ISRCTN
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ISRCTN18328134
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DOI
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10.1186/ISRCTN18328134
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised controlled trial of a low-cost intervention to promote self-help smoking cessation in pregnancy
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9711788
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Study hypothesis
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The trial aims to identify the effectiveness of low cost self-help health education materials implemented within routine UK antenatal care in helping pregnant women quit smoking, using validated smoking status at the end of the second trimester of pregnancy (27 weeks) as the primary outcome measure. Secondary aims of the research will be (i) to collect data on birth weight, gestation at delivery and stillbirth and neonatal /infant mortality to contribute to the cumulative meta-analysis of the impact of smoking cessation on these outcomes; (ii) to assess the acceptability of the booklets to the women and (iii) to assess the feasibility and cost of incorporating self-help manuals dispatched by post into routine antenatal care
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Lay summary
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Ethics approval
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Added as of 12/09/2007: Three NHS trusts agreed to participate in the study, and approval from relevant local research ethics committees were obtained.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Public health, social medicine
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Participants - inclusion criteria
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Aged 16 years or above at their first appointment with one of 40 participating midwives. Participants will be those who are less than 16 weeks pregnant at that time and who were smokers immediately prior to pregnancy.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/02/1998
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Anticipated end date
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28/02/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1500
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Interventions
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Low cost self-help health education materials/control.
There will be two experimental groups: (i) participants receiving normal antenatal care only and (ii) participants receiving the programme of self-help booklets in addition to normal antenatal care. 112 participating midwives will be randomly allocated to the two groups: during the period of the trial, each of the midwives will deliver care according to their respective allocation to experimental group to all their patients satisfying the inclusion criteria.
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Primary outcome measure(s)
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Primary end point: smoking cessation rate (validated by urinary cotinine assay) at end of second trimester of pregnancy (27 weeks).
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Secondary outcome measure(s)
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Secondary end points: birth weight and gestation at delivery. The acceptability of the intervention to participants and midwives, aspects of programme content and delivery and programme costs will also be assessed
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12480850
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Contact name
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Dr
Laurence
Moore
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Address
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Department of Social Medicine
University of Bristol
Canynge Hall
Whiteladies Road
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City/town
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Bristol
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Zip/Postcode
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BS8 2PR
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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12/09/2007
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Date ISRCTN assigned
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25/10/2000
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