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临床试验/NCT01252706
NCT01252706Unknown不适用

Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
10,000
试验地点
1
主要终点
nicotine, alcohol and drug abstinence

研究概览

简要总结

The aims is to evaluate the rate of exposure to alcohol, psychoactive substance and nicotine among pregnant women in periphery hospital (Poria) and in the center of Tel Aviv (Ichilov) and to evaluate study Brief Intervention impact on reduction exposure, and its effect on newborn outcomes.

详细描述

All pregnant women who will arrive to Poria (and third of pregnant who will arrive to Ichilov) ER, high risk, and follow-up clinic will be asked for alcohol exposure, smoking and psychoactive substance usage. Relevant women will be asked to participate in a brief intervention treatment for about 30 min by expert personal, and a follow-up by phone every 3 months during pregnancy and post deliver. In addition, through all the year, questionnaires about exposure will be given to all women who will have labor (about 3000 labors), and third of 10,000 expecting in Ichilov. We expect in the second half of the year, to have those who enrolled to the BI. New-born outcome of the BI group as compared to the non-BI group will be compared, as well as rate of alcohol/substance/nicotine abstinence and reduction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women who smoke cigarets, drink alcohol and or abuse any drugs

排除标准

  • pregnant women who do not smoke cigarets, drink alcohol and or abuse any drugs

结局指标

主要结局

nicotine, alcohol and drug abstinence

时间窗: during pregnancy until labor

nicotine alcohol and drug abstinence will be evaluate during pregnancy until labor

次要结局

  • newborn weight of birth(at labor)

研究者

申办方类型
Other Gov

研究点 (1)

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