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 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
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.


CONCLUSIONS
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.
Coleman
Tim
T
Division of Primary Care, University of Nottingham, Nottingham, UK. tim.coleman@nottingham.ac.uk
Thornton
Jim
J
Britton
John
J
Lewis
Sarah
S
Watts
Kim
K
Coughtrie
Michael W H
MW
Mannion
Clare
C
Marlow
Neil
N
Godfrey
Christine
C
D000293:Adolescent; D000328:Adult; D003362:Cost-Benefit Analysis; D003376:Counseling; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D009538:Nicotine / Q000008:administration & dosage / Q000627:therapeutic use*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012449:Safety; D012650:Self Disclosure; D012907:Smoking / Q000009:adverse effects / Q000523:psychology; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology; D000074606:Smoking Prevention; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D006113:United Kingdom
D009538:Nicotine