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临床试验/ISRCTN13835237
ISRCTN13835237
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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。

注册库
who.int
开始日期
2019年11月27日
结束日期
2021年10月31日
最后更新
去年
研究类型
Observational
性别
Female

研究者

发起方
St George’s University Hospitals NHS Foundation Trust

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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