EUCTR2004-002621-46-GB
Active, not recruiting
Phase 1
Double-blind, randomised, placebo-controlled trial of nicotine replacement therapy in pregnancy - Smoking, Nicotine and Pregnancy (SNAP) Trial
niversity of Nottingham0 sites1,050 target enrollmentJune 2, 2005
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- niversity of Nottingham
- Enrollment
- 1050
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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