Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-01-18 @ 4:50 PM
Study NCT ID:
NCT02866058
Status:
COMPLETED
Last Update Posted:
2016-08-15
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-27', 'releaseDate': '2022-09-06'}, {'resetDate': '2024-05-02', 'releaseDate': '2023-11-30'}, {'resetDate': '2024-05-14', 'releaseDate': '2024-05-06'}, {'resetDate': '2024-12-11', 'releaseDate': '2024-11-29'}, {'resetDate': '2025-01-15', 'releaseDate': '2025-01-14'}, {'resetDate': '2025-07-22', 'releaseDate': '2025-07-22'}, {'resetDate': '2025-07-23', 'releaseDate': '2025-07-23'}], 'estimatedResultsFirstSubmitDate': '2022-09-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1703590}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perinatal Mortality', 'timeFrame': 'up to 7 days', 'description': 'Includes deaths at any age if infant continuously hospitalized (including transfers) in an acute care facility. Includes deaths up to 7 days of age if infant discharged from hospital then readmitted prior to 7 days of age.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy Complications', 'Cesarean Section']}, 'descriptionModule': {'briefSummary': 'This study will examine the effect of cesarean section on perinatal mortality, using data provided by the Canadian Institute for Health Information.', 'detailedDescription': 'This study will examine administrative data provided by the Canadian Institute for Health Information (CIHI). Maternal obstetrical delivery and neonatal hospitalization records provided by CIHI will be linked before analysis. The primary outcome is in-hospital perinatal mortality. The data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the Generalized Method of Moments. The instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. All analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All obstetrical deliveries in Canada (except the province of Quebec) between April 1, 2006 and March 31, 2009', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers living in Canada and their infants delivering within the study period at Canadian hospitals outside of the province of Quebec.\n\nExclusion Criteria:\n\n* Maternal record not linkable to neonatal record.\n* Multiple gestation.\n* Birthweight \\< 500 gm.\n* Gestational age at delivery \\< 20 weeks.\n* Deliveries at hospitals with less than 20 cesarean deliveries during study period.\n* Records with missing data for important covariates'}, 'identificationModule': {'nctId': 'NCT02866058', 'briefTitle': 'Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Memorial University of Newfoundland'}, 'officialTitle': 'Substantial Variability Between Traditional and Instrumental Variable Estimates of the Risk of Caesarean Section in Canada: a Population-based Cohort Study', 'orgStudyIdInfo': {'id': 'MRFCoxAwardAubrey2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cesarean', 'description': 'Mothers delivered by cesarean section', 'interventionNames': ['Procedure: Cesarean Section']}, {'label': 'Vaginal', 'description': 'Mothers delivered by vaginal delivery'}], 'interventions': [{'name': 'Cesarean Section', 'type': 'PROCEDURE', 'armGroupLabels': ['Cesarean']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kris Aubrey-Bassler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data provider does not allow sharing of investigator data, but data can be requested directly from them.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Foundation - Memorial University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Primary Healthcare Research Unit', 'investigatorFullName': 'Kris Aubrey-Bassler', 'investigatorAffiliation': 'Memorial University of Newfoundland'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-09-06', 'type': 'RELEASE'}, {'date': '2023-07-27', 'type': 'RESET'}, {'date': '2023-11-30', 'type': 'RELEASE'}, {'date': '2024-05-02', 'type': 'RESET'}, {'date': '2024-05-06', 'type': 'RELEASE'}, {'date': '2024-05-14', 'type': 'RESET'}, {'date': '2024-11-29', 'type': 'RELEASE'}, {'date': '2024-12-11', 'type': 'RESET'}, {'date': '2025-01-14', 'type': 'RELEASE'}, {'date': '2025-01-15', 'type': 'RESET'}, {'date': '2025-07-22', 'type': 'RELEASE'}, {'date': '2025-07-22', 'type': 'RESET'}, {'date': '2025-07-23', 'type': 'RELEASE'}, {'date': '2025-07-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kris Aubrey-Bassler, Director, Primary Healthcare Research Unit, Memorial University of Newfoundland'}}}}