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
1 other identifier
observational
100,000
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
November 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 2, 2019
November 1, 2019
2.4 years
November 12, 2019
November 28, 2019
Conditions
Outcome Measures
Primary Outcomes (9)
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)
Study Arms (16)
Beijing
Guangzhou
Jinan
Nanjing
Hangzhou
Wuhan
Zunyi
Xiangyang
Nantong
Suizhou
Huangshi
Changzhou
Suqian
Shiyan
Xiaogan
Huanggang
Interventions
This is a multi-city observational cohort study without intervention.
Eligibility Criteria
Pregnant women attending their first routine antenatal examinations.
You may qualify if:
- pregnancy within 13 weeks;
- age between 20-45 years;
- natural conception;
- singleton pregnancy;
- living in the local area for one year or more.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jinling Hospital, Chinalead
- Peking Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Shandong Universitycollaborator
- Zunyi Medical Collegecollaborator
- Zhejiang Universitycollaborator
- Huazhong University of Science and Technologycollaborator
Study Sites (19)
Haidian Maternal and Child Healthcare Hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Meitan People's Hospital
Zunyi, Guizhou, China
Renhuai Hospital of Traditional Chinese Medicine
Zunyi, Guizhou, China
The First Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Second Affliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
People's Hospital of Qichun County
Huanggang, Hubei, China
Huangshi Maternal and Child Healthcare Hospital
Huangshi, Hubei, China
Shiyan Maternal and Child Healthcare Hospital
Shiyan, Hubei, China
Maternal and Child Healthcare and Family Planning Service Center of Zengdu District
Suizhou, Hubei, China
Huangpi Maternal and Child Healthcare Hospital
Wuhan, Hubei, China
Maternal and Child Healthcare Hospital of HuBei
Wuhan, Hubei, China
Xiangyang No. 1 People's Hospital, Hubei University of Medicine
Xiangyang, Hubei, China
Anlu Maternal and Child healthcare Hospital
Xiaogan, Hubei, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, China
Nantong Maternal and Child Healthcare Hospital
Nantong, Jiangsu, China
Shuyang Hospital Affiliated to Xuzhou Medical University
Suqian, Jiangsu, China
Center for Reproductive Medicine, Shandong University
Jinan, Shandong, China
Women's Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China
Biospecimen
The investigators will collect a 8 ml blood sample and a 10 ml urine sample from each pregnant woman at their first pregnancy examination, and a 10 ml cord blood sample at delivery. The blood sample will be separated into plasma/serum and white blood cells/blood clots shortly after collection and then stored at -80 degrees celsius. The urine sample will be separated into several tubes before storage at -80 degrees celsius.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuejun Shang, PhD
Jinling Hospital, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 12, 2019
First Posted
December 2, 2019
Study Start
August 12, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
December 2, 2019
Record last verified: 2019-11