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

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 cess...

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Autores principales: Coleman, Tim, Thornton, Jim, Britton, John, Lewis, Sarah, Watts, Kim, Coughtrie, Michael WH, Mannion, Clare, Marlow, Neil, Godfrey, Christine
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764871/
https://www.ncbi.nlm.nih.gov/pubmed/17201904
http://dx.doi.org/10.1186/1472-6963-7-2
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author Coleman, Tim
Thornton, Jim
Britton, John
Lewis, Sarah
Watts, Kim
Coughtrie, Michael WH
Mannion, Clare
Marlow, Neil
Godfrey, Christine
author_facet Coleman, Tim
Thornton, Jim
Britton, John
Lewis, Sarah
Watts, Kim
Coughtrie, Michael WH
Mannion, Clare
Marlow, Neil
Godfrey, Christine
author_sort Coleman, Tim
collection PubMed
description 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.
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spelling pubmed-17648712007-01-10 Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy Coleman, Tim Thornton, Jim Britton, John Lewis, Sarah Watts, Kim Coughtrie, Michael WH Mannion, Clare Marlow, Neil Godfrey, Christine BMC Health Serv Res Study Protocol 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. BioMed Central 2007-01-03 /pmc/articles/PMC1764871/ /pubmed/17201904 http://dx.doi.org/10.1186/1472-6963-7-2 Text en Copyright © 2007 Coleman et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Coleman, Tim
Thornton, Jim
Britton, John
Lewis, Sarah
Watts, Kim
Coughtrie, Michael WH
Mannion, Clare
Marlow, Neil
Godfrey, Christine
Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title_full Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title_fullStr Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title_full_unstemmed Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title_short Protocol for the Smoking, Nicotine and Pregnancy (SNAP) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
title_sort protocol for the smoking, nicotine and pregnancy (snap) trial: double-blind, placebo-randomised, controlled trial of nicotine replacement therapy in pregnancy
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1764871/
https://www.ncbi.nlm.nih.gov/pubmed/17201904
http://dx.doi.org/10.1186/1472-6963-7-2
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