Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-06-24 @ 11:26 PM
Study NCT ID:
NCT03561766
Status:
RECRUITING
Last Update Posted:
2019-12-12
First Post:
2018-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Birth Cohort Study of China Medical University
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During pregnancy: maternal blood, urine and stool ; fetal blood and oral mucosal cell At delivery: cord, cord blood and placenta During Infancy：dry blood spot During childhood: blood, buccal swab and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2037-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2018-05-21', 'studyFirstSubmitQcDate': '2018-06-17', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of biometric parameter in centimeter of fetuses at the thirteenth week of gestational age', 'timeFrame': 'At every week from the thirteenth week of gestational age to delivery of babies', 'description': 'Including head circumference, abdominal circumference, biparietal diameter, femur length of singleton and twin pregnancy'}, {'measure': 'Weight in kilogram of neonate', 'timeFrame': 'At birth of neonate', 'description': 'Including singleton and twin pregnancy measured by nurses'}, {'measure': 'Gene expression of husbands of pregnancy women', 'timeFrame': 'At 13 weeks of gestational age', 'description': 'DNA methylation, histone acetylation etc. assessed by analyses of blood'}, {'measure': 'Change of gene expression of pregnancy women', 'timeFrame': 'At 13, 26 and 34 weeks of gestational age', 'description': 'DNA methylation, histone acetylation etc. assessed by analyses of blood'}, {'measure': 'Result of Non-invasive Prenatal Testing', 'timeFrame': 'From 12 to 22 weeks of gestational age', 'description': 'including singleton and twin pregnancy'}], 'secondaryOutcomes': [{'measure': 'Change of intestinal flora during early childhood', 'timeFrame': 'Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years', 'description': 'Assessed by analyses of stool samples'}, {'measure': 'Height in centimeter changes during childhood', 'timeFrame': 'Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years', 'description': 'Measured by nurses in clinic'}, {'measure': 'Weight in kilogram changes during childhood', 'timeFrame': 'Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years', 'description': 'Measured by nurses in clinic'}, {'measure': 'Change of gene expression during childhood', 'timeFrame': 'Age at 1 year, 3 years, 6 years, 9 years, 12 years, 15 years and 18 years', 'description': 'DNA methylation, histone acetylation etc. assessed by analyses of blood'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Twin; Complicating Pregnancy', 'Advanced Maternal Age Pregnancy', 'Scarred Uterus', 'Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '40158174', 'type': 'DERIVED', 'citation': 'Zhang L, Du Y, Zhou J, Liu C, Li J, Qiao C. Timing of diagnostic workups in Chinese population with recurrent pregnancy loss: a cross-sectional study. BMC Pregnancy Childbirth. 2025 Mar 29;25(1):373. doi: 10.1186/s12884-025-07330-8.'}]}, 'descriptionModule': {'briefSummary': 'The CMUBCS is a birth cohort study located in Shenyang, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. Data are collected regarding environmental factors, family and lifestyle, clinical experimental outcomes and imaging results of pregnant women and children from birth to 18 years old. Biological samples including blood and tissue samples are also collected from the children and their parents.', 'detailedDescription': "Early life phase (fetal and infant) is a critical period for the development of health and disease in a person's life. Many adult chronic diseases, such as diabetes, cardiovascular and cerebrovascular diseases, all come from the exposure of negative environmental and behavioral factors during this period. By collecting the lifestyle data and clinical data of pregnant women at different periods, the appropriate indicators are anticipated to be selected to predict and evaluate the outcome of pregnancy and the health of the mothers and children in the long term. The status of overweight and obesity of children in Shenyang and its surrounding areas are anticipated to be analyzed by descriptive and etiological analysis through collecting the lifestyle data and clinical data of different periods of pregnant women and the lifestyle data of different developmental stages of children."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women in Shenyang, China and their husband and children', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women, \\<13 gestational weeks\n2. Permanent residents or families intended to remain in Shenyang and surrounding areas\n3. Pregnant women who are planned to be examined and delivered in Shengjing Hospital.\n\nExclusion Criteria:\n\n1. Pregnant women who refuse to take part in the study\n2. Pregnant women have diseases that might affect the results of researches, including neuropsychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT03561766', 'briefTitle': 'Birth Cohort Study of China Medical University', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Birth Cohort Study of China Medical University in Shenyang', 'orgStudyIdInfo': {'id': 'CMUBCS'}}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaowei Yin, PhD', 'role': 'CONTACT', 'email': 'yinsw1984@163.com', 'phone': '86-18902458403'}, {'name': 'Jiajin Hu, PhD', 'role': 'CONTACT', 'email': '495403966@qq.com', 'phone': '86-18940287190'}], 'facility': 'Shengjing Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Caixia Liu', 'role': 'CONTACT', 'email': 'liucx1716@163.com', 'phone': '86-18902451716'}, {'name': 'Shaojiang Liu', 'role': 'CONTACT', 'email': 'liushaojiang1995@qq.com', 'phone': '86-18002454803'}], 'overallOfficials': [{'name': 'Caixia Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the second obstetrical department', 'investigatorFullName': 'Caixia Liu', 'investigatorAffiliation': 'Shengjing Hospital'}}}}