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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; Cooper, Sue; Thornton, Jim; Britton, John; Lewis, Sarah; Watts, Kim; Coughtrie, Michael; Mannion, Clare; Marlow, Neil; Godfrey, Christine; Grainge, Matthew J.

Authors

Tim Coleman tim.coleman@nottingham.ac.uk

Sue Cooper sue.cooper@nottingham.ac.uk

Jim Thornton

John Britton

Sarah Lewis

Kim Watts

Michael Coughtrie

Clare Mannion

Neil Marlow

Christine Godfrey

Matthew J. Grainge



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.

Other Type Other
APA6 Citation Coleman, T., Cooper, S., Thornton, J., Britton, J., Lewis, S., Watts, K., …Grainge, M. J. Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy
Keywords Protocol,
Statistical Analysis Plan,
Randomised controlled trial,
Smoking cessation,
Pregnancy,
Nicotine replacement therapy,
Child development
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
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

Files

SNAP_trial_protocol_Final_v7.0_11_Jun_09.pdf (325 Kb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf


12_12_12_SNAP_statistical_analysis_plan_incorporating_follow_up_analyses_Final_Version_3_0_12_Dec_2012.pdf (594 Kb)
PDF

Copyright Statement
Copyright information regarding this work can be found at the following address: http://eprints.nottingham.ac.uk/end_user_agreement.pdf





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