Environmental Factors and Embryonic Development Project

Preterm Birth Clinical Trial

— EFED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182503
• Other study ID #: 2018YFC1004300
• Status: Recruiting
• Start date: August 12, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2019
• Source: Nanjing Jinling Hospital
• Contact: Xuejun Shang, PhD
• Phone: 025-84815775
• Email: shangxj98[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Haidian Maternal and Child Healthcare Hospital	Beijing	Beijing
China	Changzhou Second People's Hospital	Changzhou	Jiangsu
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Women's Hospital, School of Medicine, Zhejiang University	Hanzhou	Zhejiang
China	People's Hospital of Qichun County	Huanggang	Hubei
China	Huangshi Maternal and Child Healthcare Hospital	Huangshi	Hubei
China	Center for Reproductive Medicine, Shandong University	Jinan	Shandong
China	Nantong Maternal and Child Healthcare Hospital	Nantong	Jiangsu
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	Shuyang Hospital Affiliated to Xuzhou Medical University	Suqian	Jiangsu
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	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

Sponsors (7)

Lead Sponsor	Collaborator
Nanjing Jinling Hospital	Huazhong University of Science and Technology, Peking University, Shandong University, Sun Yat-sen University, Zhejiang University, Zunyi Medical University

Country where clinical trial is conducted

China, 

Outcome

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