ISRCTN13835237
已完成
未知
Maternal exposure to carcinogens, toxicants and nicotine during pregnancy among e-cigarette users, smokers, nicotine replacement therapy users and among those who have never used nicotine or tobacco products
St George’s University Hospitals NHS Foundation Trust0 个研究点目标入组 149 人2019年11月27日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- se of nicotine and tobacco products during pregnancy
- 发起方
- St George’s University Hospitals NHS Foundation Trust
- 入组人数
- 149
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Pregnant women
- •2\. Aged at least 16 years of age
- •3\. Able to speak and read English
- •4\. Do not report having had an active infection (chest infection, cold or flu, sore throat, or fever) within 24 hours of either of the two assessments
- •5\. Willing and able to give informed consent for participation in the study
- •6\. Meet criteria for one of six groups related to level and type of use of nicotine and tobacco products:
- •6\.1\. Group A. ‘Exclusive smokers’: Smoked more than 5 cigarettes every day for more than the last six months and have not vaped or used NRT in the last month
- •6\.2\. Group B. ‘ECs only’: Not smoked cigarettes for at least a month and have vaped every day for at least the last two weeks. Also, have not used NRT in the last month
- •6\.3\. Group C. ‘NRT only': Not smoked cigarettes for at least a month and have used NRT every day for at least the last two weeks. Also, have not vaped in the last month
- •6\.4\. Group D. Dual users of cigarettes and ECs: Smoked cigarettes on most days of the week for more than 6 months. Also, have been using e\-cigarettes on most days of the week for at least the last two weeks
排除标准
- •Current participant exclusion criteria as of 20/10/2021:
- •1\. Have used tobacco products other than cigarettes in the last month (e.g., cigars, heat\-not\-burn)
- •2\. Have used both NRT and ECs in the last month
- •3\. Have used nicotine free e\-cigarettes in the last month
- •4\. Report having had an active infection (chest infection, cold or flu, sore throat, or fever) within 24 hours of either of the two assessments
- •5\. Reported as not currently smoking with an expired carbon monoxide reading of \>3 parts per million (where an expired carbon monoxide reading has been obtained)
- •Previous participant exclusion criteria:
- •1\. Have used tobacco products other than cigarettes in the last month (e.g., cigars, heat\-not\-burn)
- •2\. Have used both NRT and ECs in the last month
- •3\. Have used nicotine free e\-cigarettes in the last month
结局指标
主要结局
未指定
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