Spontaneous AbortionEFEDNCT04182503
Environmental Factors and Embryonic Development Project
An observational study of Spontaneous Abortion and Fetal Death, run by Jinling Hospital, China at 19 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Abortion, Fetal Death, Stillbirth
- How many people
- 100,000 participants
- Where
- 19 sitesChina
- Study dates
- 12 Aug 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women attending their first routine antenatal examinations.
Who may be able to join
- pregnancy within 13 weeks;
- age between 20-45 years;
- natural conception;
- singleton pregnancy;
- living in the local area for one year or more.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 1 recruiting
- Recruiting
Haidian Maternal and Child Healthcare Hospital
Beijing, Beijing Municipality
Lei Jin, PhD, 8615510251021, jinlei@bjmu.edu.cn
Qi Wang
- Active, not recruiting
Changzhou Second People's Hospital
Changzhou, Jiangsu
- Active, not recruiting
Guangdong General Hospital
Guangzhou, Guangdong
- Active, not recruiting
Women's Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang
- Active, not recruiting
People's Hospital of Qichun County
Huanggang, Hubei
- Active, not recruiting
Huangshi Maternal and Child Healthcare Hospital
Huangshi, Hubei
- Active, not recruiting
Center for Reproductive Medicine, Shandong University
Jinan, Shandong
- Active, not recruiting
Nantong Maternal and Child Healthcare Hospital
Nantong, Jiangsu
- Active, not recruiting
Shiyan Maternal and Child Healthcare Hospital
Shiyan, Hubei
- Active, not recruiting
Maternal and Child Healthcare and Family Planning Service Center of Zengdu District
Suizhou, Hubei
- Active, not recruiting
Shuyang Hospital Affiliated to Xuzhou Medical University
Suqian, Jiangsu
- Active, not recruiting
Huangpi Maternal and Child Healthcare Hospital
Wuhan, Hubei
- Active, not recruiting
Maternal and Child Healthcare Hospital of HuBei
Wuhan, Hubei
- Active, not recruiting
Xiangyang No. 1 People's Hospital, Hubei University of Medicine
Xiangyang, Hubei
- Active, not recruiting
Anlu Maternal and Child healthcare Hospital
Xiaogan, Hubei
- Active, not recruiting
Meitan People's Hospital
Zunyi, Guizhou
- Active, not recruiting
Renhuai Hospital of Traditional Chinese Medicine
Zunyi, Guizhou
- Active, not recruiting
The First Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
- Active, not recruiting
The Second Affliated Hospital of Zunyi Medical University
Zunyi, Guizhou
About this study
Official title: 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.
Read the 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.
- Conditions
- Spontaneous Abortion, Fetal Death, Stillbirth, Birth Defects, Preterm Birth, Low Birth Weight
- Being tested
- No intervention
- Medical subject headings
- Abortion, Spontaneous, Fetal Death, Stillbirth, Congenital Abnormalities, Premature Birth, Diabetes, Gestational, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a multi-city observational cohort study without intervention.
| Study group | Role | What they receive |
|---|---|---|
| Beijing | Not described Receives: Other: No intervention | |
| Guangzhou | Not described Receives: Other: No intervention | |
| Jinan | Not described Receives: Other: No intervention | |
| Nanjing | Not described Receives: Other: No intervention | |
| Hangzhou | Not described Receives: Other: No intervention | |
| Wuhan | Not described Receives: Other: No intervention | |
| Zunyi | Not described Receives: Other: No intervention | |
| Xiangyang | Not described Receives: Other: No intervention | |
| Nantong | Not described Receives: Other: No intervention | |
| Suizhou | Not described Receives: Other: No intervention | |
| Huangshi | Not described Receives: Other: No intervention | |
| Changzhou | Not described Receives: Other: No intervention | |
| Suqian | Not described Receives: Other: No intervention | |
| Shiyan | Not described Receives: Other: No intervention | |
| Xiaogan | Not described Receives: Other: No intervention | |
| Huanggang | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spontaneous abortion
Measured: up to 28 gestational weeks
Incidence of fetal death/stillbirth
Measured: after 20 gestational weeks to delivery
Incidence of birth defects
Measured: Delivery
Incidence of low birth weight
Measured: Delivery
Incidence of preterm birth
Measured: Delivery
Incidence of pregnancy with heart disease
Measured: During pregnancy (up to 10 months)
Incidence of pregnancy with hyperthyroidism
Measured: During pregnancy (up to 10 months)
Incidence of gestational diabetes
Measured: During pregnancy (up to 10 months)
Incidence of gestational hypertension
Measured: During pregnancy (up to 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start12 Aug 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Sun Yat-sen University, Shandong University, Zunyi Medical College, Zhejiang University, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, SHANG Xue-jun, Jinling Hospital, China
- Investigators
- Xuejun Shang, PhD, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182503
- Sponsor's protocol ID
- 2018YFC1004300
- Acronym
- EFED
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring
- ClinicalTrials.gov ID
- NCT04182503
- Acronym / sponsor ID
- EFED / 2018YFC1004300
- Conditions
- Spontaneous Abortion, Fetal Death, Stillbirth, Birth Defects, Preterm Birth, Low Birth Weight
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- Peking University, Sun Yat-sen University, Shandong University, Zunyi Medical College, Zhejiang University, Huazhong University of Science and Technology
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Beijing | – | Other: No intervention |
| Guangzhou | – | Other: No intervention |
| Jinan | – | Other: No intervention |
| Nanjing | – | Other: No intervention |
| Hangzhou | – | Other: No intervention |
| Wuhan | – | Other: No intervention |
| Zunyi | – | Other: No intervention |
| Xiangyang | – | Other: No intervention |
| Nantong | – | Other: No intervention |
| Suizhou | – | Other: No intervention |
| Huangshi | – | Other: No intervention |
| Changzhou | – | Other: No intervention |
| Suqian | – | Other: No intervention |
| Shiyan | – | Other: No intervention |
| Xiaogan | – | Other: No intervention |
| Huanggang | – | Other: No intervention |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women attending their first routine antenatal examinations.
Key inclusion criteria (5 listed)
- pregnancy within 13 weeks;
- age between 20-45 years;
- natural conception;
- singleton pregnancy;
- living in the local area for one year or more.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a multi-city observational cohort study without intervention. | Other | Beijing, Changzhou, Guangzhou, Hangzhou, Huanggang, Huangshi, Jinan, Nanjing, Nantong, Shiyan, Suizhou, Suqian, Wuhan, Xiangyang, Xiaogan, Zunyi |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuejun Shang, PhD principal investigator
Jinling Hospital, China
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Abortion and Fetal Death, run by Jinling Hospital, China at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuejun Shang, PhD (025-84815775, shangxj98@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of spontaneous abortion (time frame: up to 28 gestational weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.