NCT04182503

Environmental Factors and Embryonic Development Project

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Spontaneous Abortion
• Fetal Death
• Stillbirth
• Birth Defects
• Preterm Birth
• Low Birth Weight
• Pregnancy With Medical Condition (Non-Specific)
• Gestational Diabetes
• Gestational Hypertension

Interventions

Type	Name	Description
OTHER	No intervention	This is a multi-city observational cohort study without intervention.

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2019-12-02
• Last updated: 2019-12-02

Locations

19 sites across 1 country: China