Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT04182503
Status:
UNKNOWN
Last Update Posted:
2019-12-02
First Post:
2019-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Environmental Factors and Embryonic Development Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-28', 'studyFirstSubmitDate': '2019-11-12', 'studyFirstSubmitQcDate': '2019-11-28', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Abortion', 'Fetal Death', 'Stillbirth', 'Birth Defects', 'Preterm Birth', 'Low Birth Weight', 'Pregnancy With Medical Condition (Non-Specific)', 'Gestational Diabetes', 'Gestational Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women attending their first routine antenatal examinations.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pregnancy within 13 weeks;\n2. age between 20-45 years;\n3. natural conception;\n4. singleton pregnancy;\n5. living in the local area for one year or more.\n\nExclusion Criteria:\n\n1. pregnant women with serious chronic diseases and infectious diseases (such as cancer, chronic cardiovascular and cerebrovascular diseases, chronic renal failure, HIV infection);\n2. have participated in other scientific research projects;\n3. refuse to participate or are unwilling to sign informed consent.;\n4. are unable to guarantee delivery in our designated hospitals.'}, 'identificationModule': {'nctId': 'NCT04182503', 'acronym': 'EFED', 'briefTitle': 'Environmental Factors and Embryonic Development Project', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring', 'orgStudyIdInfo': {'id': '2018YFC1004300'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Beijing', 'interventionNames': ['Other: No intervention']}, {'label': 'Guangzhou', 'interventionNames': ['Other: No intervention']}, {'label': 'Jinan', 'interventionNames': ['Other: No intervention']}, {'label': 'Nanjing', 'interventionNames': ['Other: No intervention']}, {'label': 'Hangzhou', 'interventionNames': ['Other: No intervention']}, {'label': 'Wuhan', 'interventionNames': ['Other: No intervention']}, {'label': 'Zunyi', 'interventionNames': ['Other: No intervention']}, {'label': 'Xiangyang', 'interventionNames': ['Other: No intervention']}, {'label': 'Nantong', 'interventionNames': ['Other: No intervention']}, {'label': 'Suizhou', 'interventionNames': ['Other: No intervention']}, {'label': 'Huangshi', 'interventionNames': ['Other: No intervention']}, {'label': 'Changzhou', 'interventionNames': ['Other: No intervention']}, {'label': 'Suqian', 'interventionNames': ['Other: No intervention']}, {'label': 'Shiyan', 'interventionNames': ['Other: No intervention']}, {'label': 'Xiaogan', 'interventionNames': ['Other: No intervention']}, {'label': 'Huanggang', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is a multi-city observational cohort study without intervention.', 'armGroupLabels': ['Beijing', 'Changzhou', 'Guangzhou', 'Hangzhou', 'Huanggang', 'Huangshi', 'Jinan', 'Nanjing', 'Nantong', 'Shiyan', 'Suizhou', 'Suqian', 'Wuhan', 'Xiangyang', 'Xiaogan', 'Zunyi']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Jin, PhD', 'role': 'CONTACT', 'email': 'jinlei@bjmu.edu.cn', 'phone': '8615510251021'}, {'name': 'Qi Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haidian Maternal and Child Healthcare Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Meitan People's Hospital", 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Renhuai Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Zunyi', 'state': 'Guizhou', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'The Second Affliated Hospital of Zunyi Medical University', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Huanggang', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "People's Hospital of Qichun County", 'geoPoint': {'lat': 30.45143, 'lon': 114.87035}}, {'city': 'Huangshi', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Huangshi Maternal and Child Healthcare Hospital', 'geoPoint': {'lat': 30.24706, 'lon': 115.04814}}, {'city': 'Shiyan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Shiyan Maternal and Child Healthcare Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'city': 'Suizhou', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Maternal and Child Healthcare and Family Planning Service Center of Zengdu District', 'geoPoint': {'lat': 31.71111, 'lon': 113.36306}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Huangpi Maternal and Child Healthcare Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Maternal and Child Healthcare Hospital of HuBei', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xiangyang', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Xiangyang No. 1 People's Hospital, Hubei University of Medicine", 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'city': 'Xiaogan', 'state': 'Hubei', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Anlu Maternal and Child healthcare Hospital', 'geoPoint': {'lat': 30.92689, 'lon': 113.92221}}, {'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Changzhou Second People's Hospital", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Nantong', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Nantong Maternal and Child Healthcare Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Suqian', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Shuyang Hospital Affiliated to Xuzhou Medical University', 'geoPoint': {'lat': 33.94917, 'lon': 118.29583}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Center for Reproductive Medicine, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Women's Hospital, School of Medicine, Zhejiang University"}], 'centralContacts': [{'name': 'Xuejun Shang, PhD', 'role': 'CONTACT', 'email': 'shangxj98@163.com', 'phone': '025-84815775'}, {'name': 'Song Xu, PhD', 'role': 'CONTACT', 'email': 'pinexu@126.com', 'phone': '025-80861125'}], 'overallOfficials': [{'name': 'Xuejun Shang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jinling Hospital, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Shandong University', 'class': 'OTHER'}, {'name': 'Zunyi Medical College', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'SHANG Xue-jun', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}