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临床试验/NCT04182503
NCT04182503Unknown不适用

Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring

Jinling Hospital, China19 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2019年8月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100,000
试验地点
19
主要终点
Incidence of gestational diabetes

研究概览

简要总结

The Environmental Factors and Embryonic Development Project was set up to investigate environmental exposures and behavioral factors responsible for embryonic dysplasia and gestational complications in pregnant women.

详细描述

The Environmental Factors and Embryonic Development Project is about to recruit pregnant women from 16 cities, including Beijing, Guangzhou, Jinan, Nanjing, Hangzhou, Wuhan, Zunyi, Xiangyang, Nantong, Suizhou, Huangshi, Changzhou, Suqian, Shiyan, Xiaogan, and Huanggang. The project plans to recruit 6000-12000 participants in each city. Biological samples, questionnaires and data for embryonic dysplasia and gestational complications of pregnant women will be collected. The study includes four stages. In the first stage, the investigators will identify external environmental factors and behavioral factors that are associated with embryonic dysplasia and gestational complications in pregnant women based on external exposure monitoring strategies. In the second and third stages, the investigators will conduct several nested case-control studies based on our prospective cohort. Internal exposure monitoring will be applied to identify environmental endocrine disruptors which are associated with embryonic dysplasia and gestational complications in pregnant women in the second stage. In the third stage, the investigators will conduct genome-wide association study (GWAS) to screen susceptible genes or polymorphisms that are associated with embryonic dysplasia and gestational complications in pregnant women, identify any gene-environmental interactions with reference to the findings of the 1st and 2nd stages, and finally establish a comprehensive disease risk prediction model. In the fourth stage, the investigators will build animal models in order to identify the mechanisms how high-risk environmental exposures or behavioral factors as identified in the above stages may lead to embryonic dysplasia and gestational complications in pregnant women. The research team of the 16 cities are from Peking University (Beijing), Sun Yat-sen University (Guangzhou), Shandong University (Jinan), Chinese People's Liberation Army Eastern Theater General Hospital (Nanjing, Nantong, Changzhou, and Suqian), Zhejiang University (Hangzhou), Huazhong University of Science and Technology (Wuhan, Xiangyang, Suizhou, Huangshi, Shiyan, Xiaogan, and Huanggang), Zunyi Medical University (Zunyi), respectively. The core members of each research team are composed of experts from different disciplines in the field of public health.

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
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnancy within 13 weeks;
  • age between 20-45 years;
  • natural conception;
  • singleton pregnancy;
  • living in the local area for one year or more.

排除标准

  • pregnant women with serious chronic diseases and infectious diseases (such as cancer, chronic cardiovascular and cerebrovascular diseases, chronic renal failure, HIV infection);
  • have participated in other scientific research projects;
  • refuse to participate or are unwilling to sign informed consent.;
  • are unable to guarantee delivery in our designated hospitals.

结局指标

主要结局

Incidence of gestational diabetes

时间窗: During pregnancy (up to 10 months)

Incidence of pregnancy with hyperthyroidism

时间窗: During pregnancy (up to 10 months)

Incidence of low birth weight

时间窗: Delivery

Incidence of preterm birth

时间窗: Delivery

Incidence of pregnancy with heart disease

时间窗: During pregnancy (up to 10 months)

Incidence of fetal death/stillbirth

时间窗: after 20 gestational weeks to delivery

Incidence of birth defects

时间窗: Delivery

Incidence of gestational hypertension

时间窗: During pregnancy (up to 10 months)

Incidence of spontaneous abortion

时间窗: up to 28 gestational weeks

次要结局

未报告次要终点

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

SHANG Xue-jun

Professor

Jinling Hospital, China

研究点 (19)

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