Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
Study NCT ID:
NCT04390659
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2020-04-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myomectomy During Cesarean Section Is This Aright Decision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difficulty of cesarean myomectomy', 'timeFrame': 'during the procedure/surgery"', 'description': 'according to the site and type of myoma'}], 'secondaryOutcomes': [{'measure': '4concentrations of hemoglobin', 'timeFrame': 'during the procedure', 'description': 'intra operative bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstetric Labor, Premature']}, 'referencesModule': {'references': [{'pmid': '11756390', 'type': 'RESULT', 'citation': 'Ledee-Bataille N, Lapree-Delage G, Taupin JL, Dubanchet S, Frydman R, Chaouat G. Concentration of leukaemia inhibitory factor (LIF) in uterine flushing fluid is highly predictive of embryo implantation. Hum Reprod. 2002 Jan;17(1):213-8. doi: 10.1093/humrep/17.1.213.'}]}, 'descriptionModule': {'briefSummary': 'myomectomy was done during cesarean section', 'detailedDescription': 'The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'c s with uterine myoma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with diagnosed uterine myoma prior to pregnancy\n* needed cesarean sections for various indications.\n* Women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications.\n* Women with myoma diagnosed incidentally during labour.\n\nExclusion Criteria:\n\n* Refusal of the women at any time before and during the operations.\n* Cervical myoma.\n* Atonic uterus after delivery of the baby.\n* Women with bleeding disorders due to medical or obstetric causes.'}, 'identificationModule': {'nctId': 'NCT04390659', 'briefTitle': 'Myomectomy During Cesarean Section Is This Aright Decision', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Myomectomy During Cesarean Section,Is This Aright Decision', 'orgStudyIdInfo': {'id': 'khalid7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'myomectomy', 'type': 'PROCEDURE', 'description': 'The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'khalid salama', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'master sheet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical professor', 'investigatorFullName': 'khalid mohammed salama', 'investigatorAffiliation': 'Benha University'}}}}