Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT06234332
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2024-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peking University Birth Cohort in Weifang (PKUBC-WF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Pregnancy:\n\nDuring pregnancy and 42 days after delivery: the remaining peripheral blood sample (about 2ml) and urine sample (about 8ml); additional anticoagulant peripheral blood (5ml) and urine (10ml) of women and their husband (only when pregnant women were enrolled) .\n\nPre-delivery: feces (5g).\n\nAfter delivery: samples of umbilical cord blood (about 10ml), placenta (8 to 10 pieces of tissue with a diameter of 1.0cm), umbilical cord (4 pieces of tissue with a length of 1cm), meconium (5g), and heel blood (about 0.5ml)\n\nChildhood:\n\n6 months of age: extra fingertip blood (about 0.5ml). At the age of 1 and 2: urine sample (about 10ml) . At the age of 3 and 6: the remaining peripheral blood sample (about 2ml) and urine sample (about 8ml) .\n\nAt the age of 9, 12, 15 and 17: the remaining peripheral blood sample examined by blood biochemistry (about 2ml) , the remaining peripheral blood sample examined by blood routine (about 2ml) and urine routine residual urine sample (about 8ml).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2043-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-01-23', 'studyFirstSubmitQcDate': '2024-01-23', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers and morbidity of participants with pregnancy complications', 'timeFrame': 'At delivery', 'description': 'Including gestational diabetes, gestational hypertension, anemia, and hypothyroidism during pregnancy'}, {'measure': 'Numbers and morbidity of participants with adverse pregnancy outcomes', 'timeFrame': 'At delivery', 'description': 'Including preterm birth, low birth weight, macrosomia, abortion, stillbirth, and birth defects.'}], 'secondaryOutcomes': [{'measure': 'Weight in kilogram changes during childhood', 'timeFrame': 'At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years', 'description': 'Measured by health professionals in clinic'}, {'measure': 'Height in centimeter changes during childhood', 'timeFrame': 'At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years', 'description': 'Measured by health professionals in clinic'}, {'measure': 'Early Child development', 'timeFrame': 'Age at 6 weeks, 6 months and 12 months', 'description': "Measured by Ages\\&Stages Questionnaires (ASQ).There are 6 questions in each of 5 domains of development: communication, gross motor, fine motor, problem-solving skills, and adaptive skills. Each question is given a 10 (yes), 5 (sometimes), or 0 (not yet) score according to the parents' answers. The sum scores (range from 0 to 300) and scores for each domain (range from 0 to 60) are calculated. Chinese norms are available for each domain, and any domain screened \\<2 SDs below the mean is considered a positive screening. A higher ASQ score means better development."}, {'measure': 'Incidence of diabetes mellitus in women', 'timeFrame': '6 weeks after delivery and 3 years after delivery', 'description': 'Measured by health professionals in clinic'}, {'measure': 'Incidence of hypertension in women', 'timeFrame': '6 weeks after delivery and 3 years after delivery', 'description': 'Measured by health professionals in clinic'}, {'measure': 'Incidence of child overweight and obesity', 'timeFrame': 'At birth and age at 6 weeks, 6 months, 12 months, 2 years, 3 years, 6 years, 9 years, 12 years, 15 years, and 17 years', 'description': 'Measured by health professionals in clinic'}, {'measure': 'Incidence of autism spectrum disorder in children', 'timeFrame': 'Age at 2 years, 3 years', 'description': 'Measured by The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F) and Autism Behavior Checklist (ABC) scales'}, {'measure': 'Incidence of attention-deficit/hyperactivity disorder in children', 'timeFrame': 'Age at 6 years', 'description': 'Measured by The Child Behavior Checklist (CBC) scale'}, {'measure': 'Incidence of anxiety in adolescents', 'timeFrame': 'Age at 9 years, 12 years, 15 years, and 17 years', 'description': 'Measured by Social Anxiety Scale for Adolescents (SAS-A) scale'}, {'measure': 'Incidence of depression in adolescents', 'timeFrame': 'Age at 9 years, 12 years, 15 years, and 17 years', 'description': 'Measured by Beck Depression Inventory-II (BDI-II) scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Problems in Pregnancy', 'Pregnancy Outcomes', 'Gestational Diabetes', 'Gestational Hypertension', 'Preterm Birth', 'Obesity', 'Mother-Infant Interaction', 'Child Development', 'Anemia']}, 'descriptionModule': {'briefSummary': 'The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.', 'detailedDescription': 'Maternal and child health is of great concern globally. Early life phase of a fetus and infant is a critical period for the development of health and disease in the whole life. Exposure of negative environmental, nutritional and lifestyle factors in pregnant women during this period can have adverse effects on fetal and infant. In addition, for mothers, complications during pregnancy could also have a negative effect on long-term health of mothers, such as diabetes, hypertension. Thus, the Peking University Birth Cohort in Weifang is primarily aimed to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers, husbands and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces samples are also collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women and their children in Weifang, China', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant woman\n\n 1. Pregnant women, 6-13\\^+6 gestational weeks\n 2. Resided in Weifang in the past half years and have no plan to move out after delivery\n 3. Pregnant women who plan to have antenatal care and delivery in Weifang maternal\\&Child Hospital.\n 4. Pregnant women who is willing to participate in this study with informed consent\n* Pregnant woman's husband\n\n 1. His wife was eligible for enrollment\n 2. He is the biological father of the child (his wife's current pregnancy)\n 3. Pregnant women's husband who is willing to participate in this study with informed consent\n* Offspring 4. Children born to pregnant women who met the inclusion criteria after enrolling in this study.\n\n 5\\. Before the age of 8 years, his/her mother provided written informed consent. 6. After 8 years old, he/she agreed to continue this study and signed the informed consent.\n\nExclusion Criteria:\n\n* Participants who cannot communicate normally."}, 'identificationModule': {'nctId': 'NCT06234332', 'briefTitle': 'Peking University Birth Cohort in Weifang (PKUBC-WF)', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Peking University Birth Cohort in Weifang', 'orgStudyIdInfo': {'id': 'PKUBC-WF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposure group', 'description': 'Group with environmental, nutritional or lifestyle exposures', 'interventionNames': ['Other: No Interventions']}, {'label': 'Non-exposed group', 'description': 'Group without any environmental, nutritional and lifestyle exposures'}], 'interventions': [{'name': 'No Interventions', 'type': 'OTHER', 'description': 'No intervention This is an observational study without any intervention', 'armGroupLabels': ['Exposure group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haijun Wang, Ph.D', 'role': 'CONTACT', 'email': 'whjun1@bjmu.edu.cn', 'phone': '86-010-82805583'}, {'name': 'Jue Liu, Ph.D', 'role': 'CONTACT', 'email': 'jueliu@bjmu.edu.cn', 'phone': '86-13426455743'}], 'facility': 'Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Haijun Wang, Ph.D', 'role': 'CONTACT', 'email': 'whjun1@bjmu.edu.cn', 'phone': '86-010-82805583'}, {'name': 'Jue Liu, Ph.D', 'role': 'CONTACT', 'email': 'jueliu@bjmu.edu.cn', 'phone': '86-13426455743'}], 'overallOfficials': [{'name': 'Haijun Wang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Hai-Jun Wang', 'investigatorAffiliation': 'Peking University'}}}}