Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
13/10/2014
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 Laurence Moore

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12480850

Publication citations

  1. 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.

Additional files

Editorial Notes