Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-29 @ 7:31 PM
Study NCT ID:
NCT03377894
Status:
UNKNOWN
Last Update Posted:
2017-12-19
First Post:
2017-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sharp Versus Blunt Uterine Incision Expansion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2017-12-10', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post operative pain', 'timeFrame': 'one hour after cs', 'description': 'Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4)'}, {'measure': 'intraoperative bleeding', 'timeFrame': 'from skin incision till skin closure', 'description': 'The intra-operative blood loss is evaluated by towels as follows:\n\nThe surgical towels will be weighed (gm) before and after the operation, and the difference in weight between dry and soaked towels will be calculated. Blood loss during the operation will be calculated by adding the volume of the contents of the suction bottle (ml) to the difference in weight of towels (gm) (weight of soaked towels - weight of dry towels).'}, {'measure': 'The operative time is recorded in minutes', 'timeFrame': 'from skin incision till skin closure', 'description': 'The operative time is recorded in minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \\& postoperative pain', 'detailedDescription': 'the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.\n\nThe patients are divided randomly into two groups as follows:\n\n* Group (A): undergoing blunt uterine incision expansion\n* Group (B): undergoing sharp uterine incision expansion'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancy.\n\nExclusion Criteria:\n\n* previous PID\n* any medical or psychiatric\n* patients with BMI ≥ 40\n* multigravidas\n* chronic analgesia use,\n* allergy to analgesics,\n* multiple pregnancies are also excluded'}, 'identificationModule': {'nctId': 'NCT03377894', 'briefTitle': 'Sharp Versus Blunt Uterine Incision Expansion', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain', 'orgStudyIdInfo': {'id': '336695'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Group (A) blunt incision', 'description': '100 primigravidas at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.\n\nundergoing blunt uterine incision expansion', 'interventionNames': ['Procedure: blunt uterine incision expansion']}, {'type': 'ACTIVE_COMPARATOR', 'label': '• Group (B) sharp incision', 'description': '100 primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy undergoing sharp uterine incision expansion', 'interventionNames': ['Procedure: sharp uterine incision expansion']}], 'interventions': [{'name': 'blunt uterine incision expansion', 'type': 'PROCEDURE', 'description': 'blunt uterine incision expansion', 'armGroupLabels': ['• Group (A) blunt incision']}, {'name': 'sharp uterine incision expansion', 'type': 'PROCEDURE', 'description': 'sharp uterine incision expansion', 'armGroupLabels': ['• Group (B) sharp incision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr El Ainiy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'sarah mohamed hassan', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}