Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05517018
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2022-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-08', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the formation of a uterine niche', 'timeFrame': '6 weeks', 'description': 'The formation of a niche will be considered a failure, while the absence of a niche will be considered a technical success.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterus; Scar']}, 'descriptionModule': {'briefSummary': 'We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique)', 'detailedDescription': 'It is thought that the formation of the uterine niche may be mostly due to the surgical technique.We aimed to compare 3 different uterotomy suture techniques with each other and evaluate them in terms of niche formation.1- one layer 2- double layer 3- purse string (TURAN technique).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who need to have a cesarean section will be included in the study.participants will be randomly divided into 3 groups according to the cesarean section technique.During the cesarean section, the uterus will be closed using different techniques for each of the 3 groups.6 weeks after the operation, they will be called for control and evaluated in terms of niche formation. and rezidue myometrial tissue', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have a cesarean section necessity\n* be over 18 years old\n* being younger than 40\n\nExclusion Criteria:\n\n* emergency cesarean section\n* Being under 37 weeks pregnant\n* multiple pregnancies\n* having had uterine surgery\n* uterine malformations'}, 'identificationModule': {'nctId': 'NCT05517018', 'briefTitle': 'UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'COMPARISON OF SINGLE, DOUBLE LAYER AND PURSE STRING TECHNIQUE (TURAN TECHNIQUE) STUR TYPES IN TERMS OF THE FORMATION OF UTERINE NICH FOR CLOSING THE UTERUS DURING CESERIAN SECTION', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREHmmh'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single layer uterotomy', 'description': '53 women with a single-layer uterotomy while closing the uterus during Ceserian'}, {'label': 'double layer uterotomy', 'description': '53 women with a double layer uterotomy while closing the uterus during Ceserian'}, {'label': 'purse string uterotomy', 'description': '53 women with a purse string uterotomy tecnique had used while closing the uterus during Ceserian'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32225', 'city': 'Istanbul', 'state': 'Gaziosmanpaşa', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'elif yıldız', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa Research and Education Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MEDİCAL DOCTOR', 'investigatorFullName': 'Elif Yıldız', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}