Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-24 @ 1:44 PM
Study NCT ID:
NCT03270605
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2017-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myomectomy During CS: A Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063186', 'term': 'Uterine Myomectomy'}], 'ancestors': [{'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-28', 'studyFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deficit in hemoglobin level', 'timeFrame': '24 hours', 'description': 'Preoperative hemoglobin minus postoperative hemoglobin level (in gm/dl)'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '3 hours', 'description': 'Time to complete the procedure'}, {'measure': 'Postoperative hospital stay period', 'timeFrame': '7 days', 'description': 'Time from the end of operation to discharge from hospital'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section', 'Uterine Fibroid']}, 'descriptionModule': {'briefSummary': 'To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women with uterine fibroid during the index pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who underwent elective CS with presence of uterine fibroid during the index pregnancy documented antenatal and at surgery\n\nExclusion Criteria:\n\n* Antepartum hemorrhage\n* Blood diseases or bleeding tendencies.\n* Medical conditions complicating pregnancy.\n* Performed another surgical procedure at CS other than myomectomy.'}, 'identificationModule': {'nctId': 'NCT03270605', 'briefTitle': 'Myomectomy During CS: A Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Myomectomy During Cesarean Section: A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'R/17.04.71'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CS with myomectomy', 'description': 'Women having uterine myoma with pregnancy and subjected to myomectomy during delivery by CS', 'interventionNames': ['Procedure: Myomectomy']}, {'label': 'CS without myomectomy', 'description': 'Women having uterine myoma with pregnancy and delivered by CS without myomectomy'}], 'interventions': [{'name': 'Myomectomy', 'type': 'PROCEDURE', 'description': 'Surgical removal of uterine fibroid', 'armGroupLabels': ['CS with myomectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Waleed El-refaie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Port Said University'}, {'name': 'Mohamed Hassan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University'}, {'name': 'Mohamed S Abdelhafez, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}