Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05620056
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2022-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 564760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'congenital malformations', 'timeFrame': 'up to 42 days after delivery', 'description': 'Number of births with congenital malformations'}], 'secondaryOutcomes': [{'measure': 'preterm birth', 'timeFrame': 'up to 37 gestational weeks', 'description': 'Number of pregnancies with preterm birth'}, {'measure': 'low birth weight', 'timeFrame': 'Immediately after delivery', 'description': 'Number of live births with low birth weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cohort study', 'drug exposures', 'congenital malformation', 'pregnancy', 'population-based'], 'conditions': ['Pregnancy', 'Congenital Malformation', 'Drug Exposure']}, 'descriptionModule': {'briefSummary': 'The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes.', 'detailedDescription': 'The DEEP cohort is the first population-based cohort of pregnant population in China that longitudinally documents drug uses throughout the pregnancy life course and adverse pregnancy outcomes. The main goal of the study aims to monitor and evaluate the safety of drug use through the pregnancy life course in the Chinese setting. The DEEP cohort is developed primarily based on the population-based data platforms in Xiamen, a municipal city of 5 million population in southeast China. Based on these data platforms, a pregnancy-centered registry was developed that documented health care services and outcomes in the maternal and other departments. For identifying drug uses, a drug prescription database was specifically developed by using electronic healthcare records documented in the platforms across the primary, secondary and tertiary hospitals. By linking the pregnancy registry and prescription database through a unique identifier, the DEEP cohort was developed. All the pregnant women and their offspring in Xiamen are provided with health care and followed up according to standard protocols in the region, including antenatal care, delivery care, postpartum follow-up and childhood follow-ups. The primary adverse outcomes - congenital malformations - are collected using a standardized Case Report Form.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'From January 2013, all pregnant women who registered at the Maternal and Child Health Management in Xiamen was included in this cohort.', 'genderDescription': 'All pregnant women registered at the Maternal and Child Health Management Platform were enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women who registered at the Maternal and Child Health Management Platform in Xiamen.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05620056', 'briefTitle': 'A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Population-based Study of Drug Exposures and Adverse Pregnancy Outcomes in China (DEEP)', 'orgStudyIdInfo': {'id': 'DEEP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'drug exposure', 'description': 'chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs', 'interventionNames': ['Drug: chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs']}], 'interventions': [{'name': 'chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs', 'type': 'DRUG', 'description': 'medication (i.e., chemicals drugs, biological products, patent Chinese Medicines, Chinese herbs ) exposure through the pregnancy life course', 'armGroupLabels': ['drug exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361008', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Xiamen Health and Medical Big Data Center', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}], 'overallOfficials': [{'name': 'Xin Sun', 'role': 'STUDY_CHAIR', 'affiliation': 'Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'Following the policy of Xiamen Health Commission, research institutions could apply for data access by submitting a formal study protocol, subjected to approval by the Xiamen Health and Medical Big Data Center and the Chinese Evidence-based Medicine Center. Ethical review and research registration are mandatory for all studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xiamen Health Commission', 'class': 'UNKNOWN'}, {'name': 'Xiamen Health and Medical Big Data Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Chinese Evidence-based Medicine Center', 'investigatorFullName': 'Sun Xin', 'investigatorAffiliation': 'West China Hospital'}}}}