Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-07 @ 12:51 AM
Study NCT ID:
NCT03171103
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2017-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Lupus and Adverse Pregnancy Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 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': '2020-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-27', 'studyFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2017-05-27', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maternal outcome', 'timeFrame': '3 years', 'description': 'Number of patients who have abortion,preterm labor,preeclampsia,eclampsia,accidental hemorrhage,oligohydramnios'}], 'secondaryOutcomes': [{'measure': 'fetal outcome', 'timeFrame': '3 years', 'description': 'Number of patients who have abortion,prematurity,Intrauterine growth restriction,intrauterine fetal death,still birth,low birth weight,neonatal death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus', 'Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All pregnant ladies in Beni-suef localities diagnosed as systemic lupus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pregnant ladies with settled diagnosis of systemic lupus\n\n * all pregnant ladies who first diagnosed as systemic lupus during current pregnancy\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03171103', 'briefTitle': 'Systemic Lupus and Adverse Pregnancy Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Systemic Lupus and Pregnancy Outcome in Benisuef Localities', 'orgStudyIdInfo': {'id': '2505'}}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'Momen Zakaria Mohammed mohammed', 'investigatorAffiliation': 'Beni-Suef University'}}}}