{
  "FullStudy":{
    "Rank":217588,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519440",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Aşıcıoğlu-01"
          },
          "Organization":{
            "OrgFullName":"Istanbul Bakirkoy Maternity and Children Diseases Hospital",
            "OrgClass":"OTHER_GOV"
          },
          "BriefTitle":"Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean",
          "OfficialTitle":"Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 24, 2012",
          "StudyFirstSubmitQCDate":"January 26, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 21, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 23, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Osman Aşıcıoğlu",
            "ResponsiblePartyInvestigatorTitle":"MD",
            "ResponsiblePartyInvestigatorAffiliation":"Istanbul Bakirkoy Maternity and Children Diseases Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Istanbul Bakirkoy Maternity and Children Diseases Hospital",
            "LeadSponsorClass":"OTHER_GOV"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Disruption of Uterine Incision After Cesarean Section"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "unintended extension",
              "blunt",
              "sharp",
              "maternal blood loss"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Crossover"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"1076",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"blunt",
                "ArmGroupDescription":"Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad."
              },{
                "ArmGroupLabel":"sharp",
                "ArmGroupDescription":"Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"unintended extension of uterine incision",
                "PrimaryOutcomeTimeFrame":"during the operation"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"intraoperative maternal blood loss",
                "SecondaryOutcomeTimeFrame":"after 48 hours than operation"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nTerm pregnancy(> 38 weeks of gestation)\nRequired elective cesarean delivery\nmaternal age between 18-40 years\n\nExclusion Criteria:\n\nRequired emergency cesarean delivery\nAbnormal presentation\nPlanned cesarean hysterectomy\nHistory of low segment vertical uterine incision\nHistory of classical upper segment uterine incision\nmultiple pregnancy\ncases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)\nGrand multiparity(parity>5)",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"elective cesarean delivery cases",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"İstanbul Bakırköy Maternal and Childrens Hospital",
                "LocationCity":"İstanbul",
                "LocationState":"Bakırköy",
                "LocationZip":"34274",
                "LocationCountry":"Turkey"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"12013167",
                "ReferenceType":"result",
                "ReferenceCitation":"Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000072836",
                "ConditionMeshTerm":"Surgical Wound"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8139",
                "ConditionBrowseLeafName":"Hemorrhage",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M1112",
                "ConditionBrowseLeafName":"Surgical Wound",
                "ConditionBrowseLeafAsFound":"Incision",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              }
            ]
          }
        }
      }
    }
  }
}