Randomised controlled trial of a low-cost intervention to promote self-help smoking cessation in pregnancy

ISRCTN	ISRCTN18328134
DOI	https://doi.org/10.1186/ISRCTN18328134
Secondary identifying numbers	G9711788

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 13/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Laurence Moore
Scientific

Department of Social Medicine
University of Bristol
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Three NHS trusts agreed to participate in the study, and approval from relevant local research ethics committees were obtained
Health condition(s) or problem(s) studied	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
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 study start date	01/02/1998
Completion date	28/02/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1500
Key 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.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/02/1998
Date of final enrolment	28/02/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Social Medicine

Bristol
BS8 2PR
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	14/12/2002		Yes	No