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临床试验/NCT04725734
NCT04725734Unknown不适用

Air Pollution and Daily Mobility of Pregnant Women in the Eurometropole: Identification of Critical Windows of Exposure During Pregnancy

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2021年2月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
Characteristics of the newborn

研究概览

简要总结

This study is conducted to assess the role of pregnant women's daily mobility living in the Eurometropole of Strasbourg in a context of the existence of environmental exposure disparities (PM10, PM2.5, NO2). Furthermore, this study will tend to identify the critical windows of exposure and of greater risk of the adverse pregnancy outcomes as low birth weight and prematurity.

A second question addressed in this work is to assess the relationship between the pregnant women's socio-economic status and the air pollution exposure (PM10, PM2.5, NO2).taking into account the spatio-temporal variations of the exposure as well as the critical windows of exposure during pregnancy.

The present work deals with the following question "how does the combination of environmental exposure, socio-economic status and women's daily mobility, could contribute to socio-spatial inequalities in the health of the newborn? The underlying hypothesis is that the accumulation, in given area, of environmental exposures (as PM10, PM2.5 and NO2), of unfavorable living conditions (socio-economic environment) and individual factors (specific spatio-temporal trajectory) would induce an increased risk for the health of the newborn, (more particularly in terms of birth weight and term of birth). This hypothesis is structured 4 sub-hypotheses: i) The misclassification of exposure is socially distributed among pregnant women living in the Eurometropole of Strasbourg. ii) Beyond maternal and fetal characteristics, pregnant women who reside in a more socio-economically deprived neighborhood and / or with higher levels of environmental exposure to PM10, PM2.5 and NO2 are more at risk of preterm newborn and low birth weight newborn. iii) The accumulation of environmental exposures of the pregnant women and their daily mobility over their territory during the pregnancy increase the health inequalities of the newborn. iv) The critical windows of fetal exposure to pollutants is related to the socioeconomic level of their neighborhood and to the daily mobility of the women in their territory during pregnancy. Women are included in the study at the time of their first or second trimester ultrasound. Here are the tools used in the study: Descriptive survey of their idividuals characteristics, descriptive survey of women's mobility to assess their exposure during each trimester of pregnancy.

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

入选标准

  • Pregnant women dwelling in the Eurometropole of Strasbourg
  • Women who have done ultrasound monitoring in the HUS (Hopitaux Universitaires de Strasbourg)
  • Good understanding of the French language
  • Women who give her signed agreement of non-opposition to research and / or who give her signed consent for the data collect
  • Non-inclusion criteria:
  • refusal to participate in the study
  • under-age women (<18 years old)
  • women who not have a clear understanding of the information (emergency situation, comprehension problems...)
  • Women must not be under tutorship or curatorship or under the protection of a conservator ("sauvegarde de justice")
  • Exclusion criteria:
  • premature delivery threats
  • placenta previa
  • twin pregnancy
  • pre-eclampsia

排除标准

  • 未提供

结局指标

主要结局

Characteristics of the newborn

时间窗: 7 months

Estimation of birth weight

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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