EUCTR2004-002621-46-GB进行中（未招募）1 期
Double-blind, randomised, placebo-controlled trial of nicotine replacement therapy in pregnancy - Smoking, Nicotine and Pregnancy (SNAP) Trial
niversity of Nottingham0 个研究点目标入组 1,050 人开始时间: 2005年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,050
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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