Prospective Evaluation of the Effectiveness of a Counseling Protocol to Reduce the Level of Exposure to Metallic Trace Elements (ETM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.
研究概览
简要总结
A French company (Toxseek, France, has developed a scientifically validated screening test based on a capillary determination of pollutants on a 3 cm lock of hair. The results of this screening allow physicians to discuss with their patients the question of environmental health and provide them with personalized behavioral advice in an attempt to eliminate the source of the pollutants identified.The main objective of the study is to assess the effectiveness of behavioral counseling on reducing the level of exposure to metal-type environmental pollutants (MTE) in pregnant women or women planning to have children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 18 years old
- •Patient with desire to conceive
- •1st trimester of pregnancy
- •Patient having been informed of the study and not opposing the use of the data collected
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Women under 18 years old
- •2nd and 3rd trimester of pregnancy
- •Patient objecting to the use of the data collected
- •Protected patient: adult under tutorship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
结局指标
主要结局
Proportion of patients who reduced their level of exposure within 4 months of metal avoidance advice.
时间窗: 4 months
The patient will be considered "successful" for the reduction of the exposure level, if all the metals with a "risky" exposure level during the 1st screening have gone to an exposure level "to be monitored" or "acceptable" during the 2nd screening.
次要结局
未报告次要终点