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

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

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

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

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

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

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

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

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

author email corresponding author email

BMC Health Services Research 2007, 7:2doi: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.