Environmental Factors and Embryonic Development Project

Overview

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.

Full Title of Study: “Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2021

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.

Interventions

  • Other: No intervention
    • This is a multi-city observational cohort study without intervention.

Arms, Groups and Cohorts

  • Beijing
  • Guangzhou
  • Jinan
  • Nanjing
  • Hangzhou
  • Wuhan
  • Zunyi
  • Xiangyang
  • Nantong
  • Suizhou
  • Huangshi
  • Changzhou
  • Suqian
  • Shiyan
  • Xiaogan
  • Huanggang

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of spontaneous abortion
    • Time Frame: up to 28 gestational weeks
  • Incidence of fetal death/stillbirth
    • Time Frame: after 20 gestational weeks to delivery
  • Incidence of birth defects
    • Time Frame: Delivery
  • Incidence of low birth weight
    • Time Frame: Delivery
  • Incidence of preterm birth
    • Time Frame: Delivery
  • Incidence of pregnancy with heart disease
    • Time Frame: During pregnancy (up to 10 months)
  • Incidence of pregnancy with hyperthyroidism
    • Time Frame: During pregnancy (up to 10 months)
  • Incidence of gestational diabetes
    • Time Frame: During pregnancy (up to 10 months)
  • Incidence of gestational hypertension
    • Time Frame: During pregnancy (up to 10 months)

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nanjing Jinling Hospital
  • Collaborator
    • Peking University
  • Provider of Information About this Clinical Study
    • Principal Investigator: SHANG Xue-jun, Professor – Nanjing Jinling Hospital
  • Overall Official(s)
    • Xuejun Shang, PhD, Principal Investigator, Nanjing Jinling Hospital
  • Overall Contact(s)
    • Xuejun Shang, PhD, 025-84815775, shangxj98@163.com

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