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Open Access Highly Accessed Study protocol

Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy

Tim Coleman1*, Jim Thornton2, John Britton3, Sarah Lewis3, Kim Watts4, Michael WH Coughtrie5, Clare Mannion6, Neil Marlow7 and Christine Godfrey8

Author Affiliations

1 Division of Primary Care, University of Nottingham, Nottingham, UK

2 Division of Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK

3 Division of Respiratory Medicine, University of Nottingham, Nottingham, UK

4 Academic Division of Midwifery, University of Nottingham, Nottingham, UK

5 Department of Molecular & Cellular Pathology, University of Dundee, Dundee, UK

6 Stop Smoking Service, Central Cheshire PCT, Crewe, UK

7 Academic Division of Child Health, University of Nottingham, Nottingham, UK

8 Department of Health Sciences, University of York, York, UK

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BMC Health Services Research 2007, 7:2  doi:10.1186/1472-6963-7-2

Published: 3 January 2007

Abstract

Background

Smoking in pregnancy remains a public health challenge. Nicotine replacement therapy (NRT) is effective for smoking cessation in non-pregnant people, but because women metabolise nicotine and cotinine much faster in pregnancy, it is unclear whether this will be effective for smoking cessation in pregnancy. The NHS Health Technology Assessment Programme (HTA)-funded smoking, nicotine and pregnancy (SNAP) trial will investigate whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women.

Methods/Design

Over two years, in 5 trial centres, 1050 pregnant women who are between 12 and 24 weeks pregnant will be randomised as they attend hospital for ante-natal ultrasound scans. Women will receive either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure is biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within two weeks of this) and delivery. At six months after childbirth self-reported maternal smoking status will be ascertained and two years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial will be compared in both groups.

Discussion

This trial is designed to ascertain whether or not standard doses of NRT (as transdermal patches) are effective and safe when used for smoking cessation during pregnancy.