Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT02155569
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extraperitoneal Versus Transperitoneal Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-05', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain', 'timeFrame': 'One hour before cesarean and 24 hour postoperatively', 'description': 'Perceived pain scores will be measured by an visual analog scale.'}], 'secondaryOutcomes': [{'measure': 'delivery time', 'timeFrame': '2 minutes after delivery', 'description': 'skin incision to delivery'}, {'measure': 'operation time', 'timeFrame': '5 minutes postoperatively', 'description': 'skin incision to skin closure'}, {'measure': 'hemoglobin differences', 'timeFrame': 'one hour before cesarean, 48 hour postoperatively'}, {'measure': 'need for extra analgesic', 'timeFrame': '48 hour'}, {'measure': 'nausea', 'timeFrame': '48 hour'}, {'measure': 'vomiting', 'timeFrame': '48 hour'}, {'measure': 'thoracic and shoulder pain', 'timeFrame': '48 hour'}, {'measure': 'Urogenital distress measured by Urogenital Distress Inventory', 'timeFrame': 'One hour before cesarean and 24 hour postoperatively'}, {'measure': 'Oral intake', 'timeFrame': '48 hour', 'description': 'The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hour after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cesarean, extraperitoneal', 'Cesarean', 'Pain'], 'conditions': ['Cesarean, Extraperitoneal']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cesarean (primary or repeated up to four)\n\nExclusion Criteria:\n\n* emergent cesarean\n* macrosomia (fetal weight \\> 4500 g)\n* history of major abdominal surgery\n* suspected abnormal placentation\n* placenta previa'}, 'identificationModule': {'nctId': 'NCT02155569', 'briefTitle': 'Extraperitoneal Versus Transperitoneal Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Extraperitoneal Versus Transperitoneal Cesarean Section: A Prospective Randomized Comparison', 'orgStudyIdInfo': {'id': 'atauni8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transperitoneal Cesarean', 'interventionNames': ['Procedure: Transperitoneal Cesarean']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extraperitoneal Cesarean', 'interventionNames': ['Procedure: Extraperitoneal Cesarean']}], 'interventions': [{'name': 'Extraperitoneal Cesarean', 'type': 'PROCEDURE', 'description': 'Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry', 'armGroupLabels': ['Extraperitoneal Cesarean']}, {'name': 'Transperitoneal Cesarean', 'type': 'PROCEDURE', 'description': 'Pfannenstiel-Kerr technique for laparatomy and uterine entry', 'armGroupLabels': ['Transperitoneal Cesarean']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ragıp Atakan Al', 'investigatorAffiliation': 'Ataturk University'}}}}