Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-29 @ 6:01 AM
Study NCT ID:
NCT03538106
Status:
COMPLETED
Last Update Posted:
2018-05-25
First Post:
2017-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2017-10-25', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk factors associated with a cesarean delivery in patients with diabetes type 1', 'timeFrame': '6 years', 'description': 'he statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated with a planned cesarean delivery in patients with diabetes type 1', 'timeFrame': '6 years', 'description': 'the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.'}, {'measure': 'Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1', 'timeFrame': '6 years', 'description': 'the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesrean delivery', 'Risks factors', 'Diabetes Type 1'], 'conditions': ['Pregnant Women', 'Diabetes Type 1', 'Cesrean Delivery']}, 'descriptionModule': {'briefSummary': 'Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.\n\nMethods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant women with diabetes type 1', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with diabetes type 1\n* Pregnancy initiated between 2009 and 2015\n* Pregnancy followed up in the universitary hospital center of Montpellier\n\nExclusion Criteria:\n\n* Women who deliver in an other center\n* women with intraperitoneal injections of insulin\n* twin gestation\n* termination of pregnancy'}, 'identificationModule': {'nctId': 'NCT03538106', 'briefTitle': 'Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'RECHMPL17_0332'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}