Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-03-28 @ 6:53 PM
Study NCT ID:
NCT02479932
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin-to-delivery time', 'timeFrame': '1 minute after delivery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 and 48 hour after cesarean', 'description': 'Pain will be measured by VAS'}, {'measure': 'Operation time', 'timeFrame': 'Two minutes after surgery', 'description': 'skin-to-skin operation time'}, {'measure': 'Hemoglobin differences', 'timeFrame': 'One hour before cesarean and 48 hours after cesarean'}, {'measure': 'Need for analgesic', 'timeFrame': '24 and 48 hours after cesarean', 'description': 'All analgesic given after cesarean at hospital'}, {'measure': 'Nausea', 'timeFrame': 'Two minutes and 48 hours after cesarean', 'description': 'Nausea during surgery and after surgery'}, {'measure': 'Vomiting', 'timeFrame': 'Two minutes and 48 hours after cesarean', 'description': 'Nausea during and after surgery'}, {'measure': 'Thoracic shoulder pain', 'timeFrame': '48 hours after cesarean', 'description': 'Thoracic shoulder pain after surgery'}, {'measure': 'Urogenital distress measured by Urogenital Distress Inventory', 'timeFrame': 'One hour before cesarean and 24 hours after cesarean'}, {'measure': 'Oral intake', 'timeFrame': '12 and 24 hours postoperatively', 'description': 'The percentage of patients who tolerates oral intake. Oral intake will be allowed 4-6 hours after cesarean for extraperitoneal group. For intraperitoneal group it will be allowed when patient passed gas.'}, {'measure': 'Anxiety during surgery', 'timeFrame': 'One minute after cesarean', 'description': 'Intense fear or anxiety during surgery without pain (yes or no)'}, {'measure': 'Pain during surgery', 'timeFrame': 'One minutes after surgery', 'description': 'Abdominal pain during surgery (yes or no)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extra-peritoneal cesarean', 'Intra-peritoneal cesarean'], 'conditions': ['Labor Pain']}, 'descriptionModule': {'briefSummary': 'The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cesarean\n* previous cesarean (\\<4)\n* cesarean for distocia\n\nExclusion Criteria:\n\n* emergency cesarean ( fetal distress)\n* risk of obstetrical bleeding\n* maternal coagulation defects\n* adnexial mass\n* uterin myoma at incision site'}, 'identificationModule': {'nctId': 'NCT02479932', 'briefTitle': 'A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean', 'orgStudyIdInfo': {'id': '77-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extraperitoneal cesarean', 'interventionNames': ['Other: Extraperitoneal cesarean technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transperitoneal cesarean', 'interventionNames': ['Other: Transperitoneal cesarean technique']}], 'interventions': [{'name': 'Transperitoneal cesarean technique', 'type': 'OTHER', 'description': 'Pfannenstiel-Kerr technique for laparatomy and uterine entry', 'armGroupLabels': ['Transperitoneal cesarean']}, {'name': 'Extraperitoneal cesarean technique', 'type': 'OTHER', 'description': 'Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry', 'armGroupLabels': ['Extraperitoneal cesarean']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk Üniversitesi Araştırma Hastanesi', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Yunus E TOPDAGI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}, {'name': 'Omer E Yapca, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ragıp Atakan Al', 'investigatorAffiliation': 'Ataturk University'}}}}