Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-08 @ 7:07 PM
Study NCT ID:
NCT03169205
Status:
UNKNOWN
Last Update Posted:
2017-05-30
First Post:
2017-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Mellitus With Pregnancy in Benisuef Localities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011254', 'term': 'Pregnancy in Diabetics'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal outcome', 'timeFrame': '2 years', 'description': 'No. of patients who have preeclampsia,eclampsia,preterm delivery,Cesarean section,vaginal candidiasis,premature rupture of membrane,polyhydramnios,oligohydramnios,accidental hemorrhage,birth canal injuries,puerperal sepsis,wound infection,postpartum glucose intolerance.'}], 'secondaryOutcomes': [{'measure': 'fetal outcome', 'timeFrame': '2 years', 'description': 'No. of abortion,prematurity,macrosomia,congenital anomalies,intrauterine fetal death,still birth,shoulder dystocia,brachial plexus injury,neonatal death,respiratory distress syndrome,neonatal jaundice requiring photo-therapy,neonatal hypoglycemia,'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy in Diabetics']}, 'descriptionModule': {'briefSummary': 'The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \\& fetal complications and to predict the risk factors for poor maternal, fetal \\& neonatal outcomes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pregnant ladies with Diabetes mellitus either type 1 or type 2\n* all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy\n\nExclusion Criteria:\n\n* ladies age less than 18 year or above 45'}, 'identificationModule': {'nctId': 'NCT03169205', 'briefTitle': 'Diabetes Mellitus With Pregnancy in Benisuef Localities', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Diabetes Mellitus With Pregnancy in Benisuef Localities', 'orgStudyIdInfo': {'id': '2500'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preexisting Diabetes mellitus type 1', 'interventionNames': ['Other: observation registry']}, {'label': 'preexisting Diabetes mellitus type 2', 'interventionNames': ['Other: observation registry']}, {'label': 'Gestational Diabetes mellitus', 'interventionNames': ['Other: observation registry']}], 'interventions': [{'name': 'observation registry', 'type': 'OTHER', 'description': 'observation registry', 'armGroupLabels': ['Gestational Diabetes mellitus', 'preexisting Diabetes mellitus type 1', 'preexisting Diabetes mellitus type 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}, {'city': 'Banī Suwayf', 'country': 'Egypt', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'Momen Zakaria Mohammed mohammed', 'investigatorAffiliation': 'Beni-Suef University'}}}}