{
  "FullStudy":{
    "Rank":217960,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514591",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SU-08162011-8270"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"IRB 22205",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Stanford IRB"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Stanford University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Thromboelastography in Non-elective Cesarean Delivery",
          "OfficialTitle":"Thromboelastography to Assess Hemostatic Changes in Laboring Patients Undergoing Non-elective (Intrapartum) Cesarean Delivery"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 19, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 21, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Alex James Butwick",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"Stanford University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Stanford University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.",
          "DetailedDescription":"The purpose of the study is to assess the coagulation changes that occur in laboring patients undergoing non-elective (intrapartum)Cesarean delivery using thromboelastography (TEG). TEG is a point- of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Bleeding"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Blood samples for TEG analysis."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"33",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Non-elective Cesarean Delivery",
                "ArmGroupDescription":"We will only enroll patients undergoing non-elective CS with an 'epidural top-up' for surgical anesthesia. By definition, our study will only apply to laboring women with working labor epidurals (which were provided for labor analgesia)."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)",
                "PrimaryOutcomeDescription":"This study will allow us to collect more information about the hemostatic effects that occur during non-elective Cesarean delivery. This information will add to current knowledge base (which we have published) about coagulation changes in the peripartum period in patients undergoing non-elective Cesarean section.",
                "PrimaryOutcomeTimeFrame":"pre and post cesarean delivery, an expected average of 75 minutes"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Hematologic indices",
                "SecondaryOutcomeDescription":"Hematologic indices will include: Hemoglobin concentration and platelet count.",
                "SecondaryOutcomeTimeFrame":"Pre and post cesarean delivery, an expected average of 75 minutes"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nObstetric in-patients\nLaboring patients with Epidurals for Labor Analgesia going for non-elective Cesarean\nPatients of all ethnic backgrounds will be included\nSingleton pregnancy\nASA 1 or 2\n\nExclusion Criteria:\n\nPatients with underlying coagulation disorders.\nPatients with thrombocytopenia (platelet count <100).\nPatients with pregnancy-induced hypertension, pre-eclampsia.\nPatients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.\nPatients requiring elective Cesarean delivery.\nPatients with significant obstetric or medical disease.\nNo patients <18 years of age will be recruited.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"Obstetrical laboring patients who are undergoing non-elective Cesarean delivery with an 'epidural top up' for surgical anesthesia.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Alex Butwick, MBBS, FRCA",
                "OverallOfficialAffiliation":"Stanford University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Lucile Packard Children's Hospital",
                "LocationCity":"Stanford",
                "LocationState":"California",
                "LocationZip":"94305",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"21474664",
                "ReferenceType":"background",
                "ReferenceCitation":"Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006470",
                "ConditionMeshTerm":"Hemorrhage"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8139",
                "ConditionBrowseLeafName":"Hemorrhage",
                "ConditionBrowseLeafAsFound":"Bleeding",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}