Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy
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 attende...
| Main Authors: | , , , , , , , , , , |
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| Format: | Other |
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2012
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| Online Access: | https://eprints.nottingham.ac.uk/3283/ |
| _version_ | 1848790993127604224 |
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| author | Coleman, Tim Cooper, Sue Thornton, Jim Britton, John Lewis, Sarah Watts, Kim Coughtrie, Michael Mannion, Clare Marlow, Neil Godfrey, Christine Grainge, Matthew J. |
| author_facet | Coleman, Tim Cooper, Sue Thornton, Jim Britton, John Lewis, Sarah Watts, Kim Coughtrie, Michael Mannion, Clare Marlow, Neil Godfrey, Christine Grainge, Matthew J. |
| author_sort | Coleman, Tim |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T18:21:26Z |
| format | Other |
| id | nottingham-3283 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T18:21:26Z |
| publishDate | 2012 |
| publisher | None |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-32832020-05-04T20:22:21Z https://eprints.nottingham.ac.uk/3283/ 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. 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. None 2012 Other NonPeerReviewed Coleman, Tim, Cooper, Sue, Thornton, Jim, Britton, John, Lewis, Sarah, Watts, Kim, Coughtrie, Michael, Mannion, Clare, Marlow, Neil, 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) Protocol Statistical Analysis Plan Randomised controlled trial Smoking cessation Pregnancy Nicotine replacement therapy Child development |
| spellingShingle | Protocol Statistical Analysis Plan Randomised controlled trial Smoking cessation Pregnancy Nicotine replacement therapy Child development Coleman, Tim Cooper, Sue Thornton, Jim Britton, John Lewis, Sarah Watts, Kim Coughtrie, Michael Mannion, Clare Marlow, Neil Godfrey, Christine Grainge, Matthew J. Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title | Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title_full | Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title_fullStr | Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title_full_unstemmed | Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title_short | Final Protocol and Statistical Analysis Plan for the SNAP Trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| title_sort | final protocol and statistical analysis plan for the snap trial - a randomised, double-blind, placebo-controlled trial of nicotine replacement therapy in pregnancy |
| topic | Protocol Statistical Analysis Plan Randomised controlled trial Smoking cessation Pregnancy Nicotine replacement therapy Child development |
| url | https://eprints.nottingham.ac.uk/3283/ |