Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-24 @ 12:19 PM
Study NCT ID:
NCT02136602
Status:
COMPLETED
Last Update Posted:
2014-05-13
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'pregnant over 35 weeks. medically free.single intrauterine pregnancy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2014-05-09', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study interventricular septal thickness in fetus of diabetic mother and correlate it with good glycemic control.', 'timeFrame': '6 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Maternal Diabetes Mellites Effect on Fetus']}, 'descriptionModule': {'briefSummary': 'Good glycemic control is superior to poor glycemic control in reducing risk of interventricular septal thickness among fetuses of diabetic mothers.', 'detailedDescription': 'Thick Interventricular septum is thought to be related to poor glycemic control during pregnancy, and it causes variable degree of left ventricular outflow obstruction and hypertrophic cardiomyopathy.\n\nHypertrophic cardiomyopathy requires specific management as digoxin and inotropic agents usually used in heart failure are contraindicated.\n\nSo high index of suspicion is required in fetus of diabetic mother having thick Inter ventricular septum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women with diabetes mellites', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 35 weeks pregnancy\n* diabetic mothers\n* single intrauterine pregnancy\n\nExclusion Criteria:\n\n* any other medical disorder'}, 'identificationModule': {'nctId': 'NCT02136602', 'briefTitle': 'Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Interventricular Cardiac Septal Thickness in Fetus of Diabetic Mother Correlated to Postnatal Outcome', 'orgStudyIdInfo': {'id': 'hct 4321'}}, 'contactsLocationsModule': {'locations': [{'zip': '3285', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'AinShamsU', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohammed M Elsafty, obs&gyn lecturer.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shames university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'helsayed', 'investigatorFullName': 'heba elsyed', 'investigatorAffiliation': 'Ain Shams University'}}}}