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临床试验/EUCTR2017-001237-65-GB
EUCTR2017-001237-65-GB进行中(未招募)1 期

Helping Pregnant smokers quit: A multi-centre RCT of electronic cigarettes and nicotine patches - Pregnancy Trial of E-cigarettes and Patches (PREP)

Queen Mary University of London, Joint Research Management Office0 个研究点目标入组 1,140 人开始时间: 2017年5月31日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,140

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

  • Daily smokers
  • 12 to 24 weeks pregnant
  • Wants help with stopping smoking
  • Willing to be randomised to use either NRT or EC (to avoid selective drop-out and contamination)
  • Wiling to receive 6 weekly support calls over the phone plus two follow-up calls
  • Speaks and reads English to a level that permits data collection via the telephone.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1140
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • Known allergic reaction to nicotine skin patches (a contraindication for patch use)
  • Current daily use of NRT or EC
  • Taking part in another interventional trial (as per Good Clinical Practice)
  • Serious medical problem or high-risk pregnancy at time of initial consent

研究者

发起方
Queen Mary University of London, Joint Research Management Office

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