Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-04-17 @ 11:45 AM
Study NCT ID:
NCT02736058
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2016-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Classification of Abnormal Placentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-28', 'studyFirstSubmitDate': '2016-02-22', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adherent Placenta']}, 'descriptionModule': {'briefSummary': 'Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* abnormal placental site (placenta previa)\n\nExclusion Criteria:\n\n* refusal to participate in the study\n* cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)'}, 'identificationModule': {'nctId': 'NCT02736058', 'briefTitle': 'Surgical Classification of Abnormal Placentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'orgStudyIdInfo': {'id': 'PP2202016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': 'the included pregnant females will undergo trans-abdominal sonography as well as trans-vaginal sonography , to diagnose the abnormal placentation and the results will be compared to the intra- operative as well as the pathological examination of the specimen.', 'interventionNames': ['Device: Trans- abdominal sonography', 'Device: Trans-vaginal sonography', 'Procedure: post-operative pathological specimen examination']}], 'interventions': [{'name': 'Trans- abdominal sonography', 'type': 'DEVICE', 'armGroupLabels': ['Participants']}, {'name': 'Trans-vaginal sonography', 'type': 'DEVICE', 'armGroupLabels': ['Participants']}, {'name': 'post-operative pathological specimen examination', 'type': 'PROCEDURE', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'state': 'Cairo Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Hussein, MD', 'role': 'CONTACT', 'email': 'ahmed_mhussein@live.com', 'phone': '01223515652', 'phoneExt': '002'}], 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed M Hussein, MD', 'role': 'CONTACT', 'email': 'ahmed_mhussein@live.com', 'phone': '01223515652', 'phoneExt': '002'}, {'name': 'Dina M Dakhly, MD', 'role': 'CONTACT', 'email': 'dinadakhly@gmail.com', 'phone': '01003498919', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Ahmed M Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology', 'investigatorFullName': 'Ahmed Mahmoud Hussein', 'investigatorAffiliation': 'Cairo University'}}}}