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临床试验/NCT03233984
NCT03233984已完成不适用

Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2017年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
267
试验地点
1
主要终点
program effectivness

研究概览

简要总结

Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.

Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.

Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Patients over 18
  • •Patients living in Poitiers or city around (near the immersive environment)
  • •Patients on pregnancy and who declared their pregnancy to the authority
  • •Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or Clinique Fief de Grimoire, in Poitiers.
  • •Patients giving her agreement

排除标准

  • •Patients planning to move during the study
  • •Patients under legal protection
  • •Patients expecting twins
  • •Patients unable to speak french
  • •Patients willing to give birth in another hospital than those mentionned before

研究组 & 干预措施

Leaflet only

No Intervention

Women will only receive a leaflet about endocrine disruptor at home.

non immersive program

Active Comparator

In addition of the leaflet, women will sit in the sensibilisation program that will take place in a neutral environment

干预措施: sensibilisation program "Ma maison, mon environnement santé" (Behavioral)

immersive program

Experimental

In addition of the leaflet, women will si in the sensibilisation program that will take place in an immersive environment

干预措施: sensibilisation program "Ma maison, mon environnement santé" (Behavioral)

结局指标

主要结局

program effectivness

时间窗: During the pregnancy (second and third trimester)

Assessing the Effectiveness of the Prevention Program "My Home, My Health Environment" (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).

次要结局

  • psychosocial aspects(During the pregnancy (second and third trimester))
  • Milk concentration(After the birth of the child (first year))
  • Urine concentration(During the pregnancy (second and third trimester))
  • foetal growth(After the birth of the child (first year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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