Clinical trial NCT04182503: Environmental Factors and Embryonic Development Project
Official title: Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Abortion
Fetal Death
Stillbirth
Birth Defects
Preterm Birth
Low Birth Weight
Pregnancy With Medical Condition (Non-Specific)
Gestational Diabetes
Gestational Hypertension
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
Collaborators: name: Peking University
name: Sun Yat-sen University
name: Shandong University
name: Zunyi Medical College
name: Zhejiang University
name: Huazhong University of Science and Technology
First posted: 2019-12-02
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending their first routine antenatal examinations.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of spontaneous abortion
timeFrame: up to 28 gestational weeks
measure: Incidence of fetal death/stillbirth
timeFrame: after 20 gestational weeks to delivery
measure: Incidence of birth defects
timeFrame: Delivery
measure: Incidence of low birth weight
timeFrame: Delivery
measure: Incidence of preterm birth
timeFrame: Delivery
measure: Incidence of pregnancy with heart disease
timeFrame: During pregnancy (up to 10 months)
measure: Incidence of pregnancy with hyperthyroidism
timeFrame: During pregnancy (up to 10 months)
measure: Incidence of gestational diabetes
timeFrame: During pregnancy (up to 10 months)
measure: Incidence of gestational hypertension
timeFrame: During pregnancy (up to 10 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Haidian Maternal and Child Healthcare Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Zunyi
country: China
facility: Meitan People's Hospital
state: Guizhou
city: Zunyi
country: China
facility: Renhuai Hospital of Traditional Chinese Medicine
state: Guizhou
city: Zunyi
country: China
facility: The First Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Zunyi
country: China
facility: The Second Affliated Hospital of Zunyi Medical University
state: Guizhou
city: Huanggang
country: China
facility: People's Hospital of Qichun County
state: Hubei
city: Huangshi
country: China
facility: Huangshi Maternal and Child Healthcare Hospital
state: Hubei
city: Shiyan
country: China
facility: Shiyan Maternal and Child Healthcare Hospital
state: Hubei
city: Suizhou
country: China
facility: Maternal and Child Healthcare and Family Planning Service Center of Zengdu District
state: Hubei
city: Wuhan
country: China
facility: Huangpi Maternal and Child Healthcare Hospital
state: Hubei
city: Wuhan
country: China
facility: Maternal and Child Healthcare Hospital of HuBei
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang No. 1 People's Hospital, Hubei University of Medicine
state: Hubei
city: Xiaogan
country: China
facility: Anlu Maternal and Child healthcare Hospital
state: Hubei
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong Maternal and Child Healthcare Hospital
state: Jiangsu
city: Suqian
country: China
facility: Shuyang Hospital Affiliated to Xuzhou Medical University
state: Jiangsu
city: Jinan
country: China
facility: Center for Reproductive Medicine, Shandong University
state: Shandong
city: Hanzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Jinling Hospital, China
name: Xuejun Shang, PhD
role: PRINCIPAL_INVESTIGATOR
References: