Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9711788
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Three NHS trusts agreed to participate in the study, and approval from relevant local research ethics committees were obtained
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Public health, social medicine
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Primary end point: smoking cessation rate (validated by urinary cotinine assay) at end of second trimester of pregnancy (27 weeks).
Secondary outcome measures
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
Overall trial start date
01/02/1998
Overall trial end date
28/02/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1500
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/02/1998
Recruitment end date
28/02/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Social Medicine
Bristol
BS8 2PR
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
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
Basic results (scientific)
Publication list
Publication citations
-
Results
Moore L, Campbell R, Whelan A, Mills N, Lupton P, Misselbrook E, Frohlich J, Self help smoking cessation in pregnancy: cluster randomised controlled trial., BMJ, 2002, 325, 7377, 1383.