Environmental Factors and Embryonic Development Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-12

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beijing

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Guangzhou

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Jinan

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Nanjing

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Hangzhou

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Wuhan

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Zunyi

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Xiangyang

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Nantong

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Suizhou

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Huangshi

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Changzhou

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Suqian

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Shiyan

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Xiaogan

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Huanggang

No intervention

Intervention Type OTHER

This is a multi-city observational cohort study without intervention.

Interventions

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No intervention

This is a multi-city observational cohort study without intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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SHANG Xue-jun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuejun Shang, PhD

Role: PRINCIPAL_INVESTIGATOR

Jinling Hospital, China

Locations

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Haidian Maternal and Child Healthcare Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING