孕期大气污染暴露的追踪及对健康的影响 (SEPAGES-1337)
SEPAGES : 怀孕期间接触大气污染及其对健康的影响
SEPAGES 夫妇-儿童队列由 Inserm(法国国立卫生与医学研究所)环境流行病学小组协调。 SEPAGES 队列以普通人群为基础,旨在涵盖环境健康研究的多个领域,包括内分泌干扰物和空气污染物。
主要目标是量化怀孕期间和生命最初几年的污染对三个主要健康结果的影响:生长、呼吸健康和神经发育;并更好地了解生物学机制(例如遗传分析以研究环境因素对基因表达的作用以及遗传因素对健康的作用)。 目标是包括 500 个家庭。
研究概览
详细说明
SEPAGES 是一种新型的纵向夫妻子女队列研究,在怀孕和儿童时期进行反复临床检查,从父母和孩子身上重复大量收集生物样本,使用新技术评估空气污染暴露(GPS、个人剂量计等。 ) 在整个研究过程中(怀孕期间和孩子生命的最初几年),进行了临床检查和许多生物学测试(尿液、血液、毛发)。 由于个人剂量计、GPS 和加速度计,在怀孕期间和孩子出生后的头几年,人们会多次暴露在不同的环境因素中。 在分娩和分娩期间会采集大量样本(胎盘、组织、血液、尿液、头发、胎粪和母乳)。 最后,在研究过程中,通过计算机平台向志愿者提供了一些评估问卷,以便更好地了解他们所生活的环境。
SEPAGES 队列遵循生物医学研究的规则。 在医院进行的纳入访问期间,父亲和母亲都签署了知情同意书。 已获得所有道德和数据隐私协议:201 年 11 月 13 日,人员保护委员会 (CPP) 和 CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le) 发表了赞成意见domaine de la Santé),2014 年 1 月 9 日。 该研究于 2013 年 12 月 17 日获得国家药物安全局 (ANSM) 的授权,并于 2014 年 6 月 26 日获得国家信息与自由委员会 (CNIL) 的授权。
研究类型
注册 (实际的)
联系人和位置
学习地点
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La Tronche、法国、38700
- Hopital Couple Enfant - Grenoble
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 孕妇
- < 19 孕周
- > 18 岁
- 住在格勒诺布尔地区
- 计划在位于格勒诺布尔的四个产科医院之一分娩
排除标准:
- 不会说法语
- 无法享受法国社会保障
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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妈妈们
孕妇。
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父亲们
未来的父亲。
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孩子们
分娩后的孩子。
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胎粪和一缕头发。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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临床检查:生物取样
大体时间:最多一小时
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取样:胎粪、头发、口腔细胞、鼻细胞和 g 皮肤测试
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最多一小时
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临床检查:生物取样
大体时间:最多一小时
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取样:尿液、血液(mL)
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最多一小时
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合作者和调查者
调查人员
- 首席研究员:iSABELLE Pin, MD、University Hospital, Grenoble
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 38RC13.579
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