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临床试验/ISRCTN13835237
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 人开始时间: 2019年11月27日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
149

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

性别
Female

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
  • 6.5. Group E. Dual users of cigarettes and NRT: Smoked cigarettes on most days of the week for more than 6 months. Also, have been using NRT on most days for at least the last two weeks
  • 6.6. Group F. ‘never smokers’: Have never smoked or used any nicotine or tobacco products

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
  • 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

研究者

发起方
St George’s University Hospitals NHS Foundation Trust

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