Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy

Coleman, Tim and Cooper, Sue and Thornton, Jim and Britton, John and Lewis, Sarah and Watts, Kim and Coughtrie, Michael and Mannion, Clare and Marlow, Neil and Godfrey, Christine and Grainge, Matthew J. (2012) Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy. None. (Unpublished)

[img] PDF (Protocol for the SNAP (Smoking Nicotine And Pregnancy) trial) - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
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Abstract

This NIHR HTA-funded smoking, nicotine and pregnancy (SNAP) trial investigated whether or not nicotine replacement therapy (NRT) is effective, cost-effective and safe when used for smoking cessation by pregnant women. We randomised 1050 women who were between 12 and 24 weeks pregnant as they attended hospital for ante-natal ultrasound scans. Women received either nicotine or placebo transdermal patches with behavioural support. The primary outcome measure was biochemically-validated, self-reported, prolonged and total abstinence from smoking between a quit date (defined before randomisation and set within 2 weeks of this) and delivery. At 6 months after childbirth self-reported maternal smoking status was ascertained and 2 years after childbirth, self-reported maternal smoking status and the behaviour, cognitive development and respiratory symptoms of children born in the trial were compared in both groups. This repository contains the final approved version of the protocol plus the statistical analysis plan (SAP) for both outcomes at delivery and following the 2 year follow up period after birth.

Item Type: Other
Additional Information: Protocol for the SNAP Trial is the Final Version, 7.0, dated 11 June 2009. The Statistical Analysis Plani is the Final Version, 3.0, dated 12 December 2012
Keywords: Protocol, Statistical Analysis Plan, Randomised controlled trial, Smoking cessation, Pregnancy, Nicotine replacement therapy, Child development
Schools/Departments: University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Epidemiology and Public Health
University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Child Health, Obstetrics and Gynaecology
University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Health Sciences
University of Nottingham UK Campus > Faculty of Medicine and Health Sciences > School of Medicine > Division of Primary Care
Depositing User: Cooper, Dr Sue
Date Deposited: 24 Jul 2014 16:53
Last Modified: 28 Sep 2016 12:47
URI: http://eprints.nottingham.ac.uk/id/eprint/3283

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