Environmental Factors and Embryonic Development Project (EFED)

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

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Birth; Low Birth Weight; Birth Defects; Gestational Diabetes; Fetal Death; Stillbirth; Spontaneous Abortion; Gestational Hypertension; Pregnancy With Medical Condition (Non-Specific)
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Xuejun Shang, PhD; Phone Number: 025-84815775; Email: shangxj98@163.com
• Study Contact Backup: Name: Song Xu, PhD; Phone Number: 025-80861125; Email: pinexu@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Haidian Maternal and Child Healthcare Hospital
      • Contact: Lei Jin, PhD; Phone Number: 8615510251021; Email: jinlei@bjmu.edu.cn
      • Principal Investigator: Qi Wang
  • Guangdong
    • Guangzhou, Guangdong, China
      • Active, not recruiting
      • Guangdong General Hospital
  • Guizhou
    • Zunyi, Guizhou, China
      • Active, not recruiting
      • Meitan People's Hospital
    • Zunyi, Guizhou, China
      • Active, not recruiting
      • Renhuai Hospital of Traditional Chinese Medicine
    • Zunyi, Guizhou, China
      • Active, not recruiting
      • The First Affiliated Hospital of Zunyi Medical University
    • Zunyi, Guizhou, China
      • Active, not recruiting
      • The Second Affliated Hospital of Zunyi Medical University
  • Hubei
    • Huanggang, Hubei, China
      • Active, not recruiting
      • People's Hospital of Qichun County
    • Huangshi, Hubei, China
      • Active, not recruiting
      • Huangshi Maternal and Child Healthcare Hospital
    • Shiyan, Hubei, China
      • Active, not recruiting
      • Shiyan Maternal and Child Healthcare Hospital
    • Suizhou, Hubei, China
      • Active, not recruiting
      • Maternal and Child Healthcare and Family Planning Service Center of Zengdu District
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Huangpi Maternal and Child Healthcare Hospital
    • Wuhan, Hubei, China
      • Active, not recruiting
      • Maternal and Child Healthcare Hospital of HuBei
    • Xiangyang, Hubei, China
      • Active, not recruiting
      • Xiangyang No. 1 People's Hospital, Hubei University of Medicine
    • Xiaogan, Hubei, China
      • Active, not recruiting
      • Anlu Maternal and Child healthcare Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Active, not recruiting
      • Changzhou Second People's Hospital
    • Nantong, Jiangsu, China
      • Active, not recruiting
      • Nantong Maternal and Child Healthcare Hospital
    • Suqian, Jiangsu, China
      • Active, not recruiting
      • Shuyang Hospital Affiliated to Xuzhou Medical University
  • Shandong
    • Jinan, Shandong, China
      • Active, not recruiting
      • Center for Reproductive Medicine, Shandong University
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Active, not recruiting
      • Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending their first routine antenatal examinations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

16

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Beijing	Other: No intervention; This is a multi-city observational cohort study without intervention.
Guangzhou	Other: No intervention; This is a multi-city observational cohort study without intervention.
Jinan	Other: No intervention; This is a multi-city observational cohort study without intervention.
Nanjing	Other: No intervention; This is a multi-city observational cohort study without intervention.
Hangzhou	Other: No intervention; This is a multi-city observational cohort study without intervention.
Wuhan	Other: No intervention; This is a multi-city observational cohort study without intervention.
Zunyi	Other: No intervention; This is a multi-city observational cohort study without intervention.
Xiangyang	Other: No intervention; This is a multi-city observational cohort study without intervention.
Nantong	Other: No intervention; This is a multi-city observational cohort study without intervention.
Suizhou	Other: No intervention; This is a multi-city observational cohort study without intervention.
Huangshi	Other: No intervention; This is a multi-city observational cohort study without intervention.
Changzhou	Other: No intervention; This is a multi-city observational cohort study without intervention.
Suqian	Other: No intervention; This is a multi-city observational cohort study without intervention.
Shiyan	Other: No intervention; This is a multi-city observational cohort study without intervention.
Xiaogan	Other: No intervention; This is a multi-city observational cohort study without intervention.
Huanggang	Other: No intervention; This is a multi-city observational cohort study without intervention.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Jinling Hospital
• Collaborators: Peking University; Shandong University; Sun Yat-sen University; Huazhong University of Science and Technology; Zhejiang University; Zunyi Medical College
• Investigators: Principal Investigator: Xuejun Shang, PhD, Nanjing Jinling Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Death; Hypertension; Congenital Abnormalities; Premature Birth; Birth Weight; Abortion, Spontaneous; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Fetal Death; Stillbirth
• Other Study ID Numbers: 2018YFC1004300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No