Double-blind, randomised, placebo-controlled trial of nicotine replacement therapy in pregnancy - Smoking, Nicotine and Pregnancy (SNAP) Trial
- Conditions
- Smoking during pregnancy Specifically smoking 5 or more cigarettes currently (i.e. whilst pregnant) and having smoked 10 or more cigarettes prior to pregnancy.
- Registration Number
- EUCTR2004-002621-46-GB
- Lead Sponsor
- niversity of Nottingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1050
Eligible women are women between 12 and 24 weeks pregnant, who report smoking at least ten cigarettes daily before pregnancy and who still currently smoke at least five cigarettes daily. They also must have an exhaled carbon monoxide reading above 8 ppm [i.e. which demonstrates that they are a smoker].
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Women with the following contraindications to the use of NRT will be excluded:
severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or TIA, chronic generalized skin disorders or known sensitivity to nicotine patches, chemical dependence / alcohol addiction problems.
Also, women who cannot give informed consent and those with known major fetal anomalies will be excluded.
Intra-uterine growth restriction (IUGR) is not an exclusion criterion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Self-reported, prolonged and total abstinence from smoking or the use of any non-pharmacological nicotine containing substances between a quit date set within two weeks of randomisation and immediately prior to childbirth.;Secondary Objective: To compare at 2 years after delivery: the effects of maternal nicotine replacement therapy patch and placebo patch use in pregnancy on behaviour and cognitive development in children. ;Main Objective: The SNAP trial will investigate whether or not NRT is more effective and cost effective than placebo in achieving smoking cessation for women who and are between 12 and 24 weeks pregnant, who currently smoke 5 or more cigarettes daily and who smoked 10 or more cigarettes daily before pregnancy.
- Secondary Outcome Measures
Name Time Method