{
  "FullStudy":{
    "Rank":217726,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517633",
          "OrgStudyIdInfo":{
            "OrgStudyId":"300165-HMO-CTIL"
          },
          "Organization":{
            "OrgFullName":"Hadassah Medical Organization",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine",
          "OfficialTitle":"Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 24, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 25, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hadassah Medical Organization",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.",
          "DetailedDescription":"Pregnant women sensing wetness and arriving to the delivery room with suspect PROM will use a self-testing device to test whether the wetness is caused by amniotic fluid leakage or urinary incontinence. Clinical evaluation will be performed to all pregnant women using standard clinical tests. The results of the standard clinical tests will be compared to the women's reading of the self-testing device results. Sensitivity and specificity of the device evaluation will be calculated."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Amniotic Fluid Leakage"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Amniotic fluid leakage",
              "Urinary incontinence"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2",
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"100",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"A device for identifying between amniotic fluid and urine",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: BirthSign"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"BirthSign",
                "InterventionDescription":"When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "A device for identifying between amniotic fluid and urine"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Presence / absence of stains comparing to a known color index printed on the product",
                "PrimaryOutcomeDescription":"Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the woman.",
                "PrimaryOutcomeTimeFrame":"12 hours"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Presence / absence of stains comparing to a known color index printed on the product",
                "SecondaryOutcomeDescription":"Presence / absence of a blue-green stain and / or brown-red stain as yielded by the device and observed by the clinician and a measurement of patient comfort while using the device, reading the results and clarity of instructions.",
                "SecondaryOutcomeTimeFrame":"12 hours"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPregnant women age 18 years and older attending delivery room.\nStage of gestation: pregnancy between 16 and 42 weeks of gestation.\nAble and willing to read and sign an informed consent document.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if any of the following will be present:\n\nPrior use of any amniotic fluid detection test.\nUse of vaginal douching apparatus (such as a vaginal bulb syringe) or vaginal products such as creams or gels within the past 24 hours.\nVaginal bleeding or spotting or excess abnormal vaginal discharge within the past 24 hours.\nSexual intercourse within the past 24 hours.\nConfirmed diagnosis of any vaginal infection within the past 7 days.\nUse of vaginal products or antibiotic treatments that reduce bacterial population or use of medications such as tamoxifen that reduce estrogen levels or antihistamines that dry mucous membranes within the past 7 days..\nPatients unable or unwilling to participate.\nPatients in active labor (or with regular contractions).",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hadassah Medical Organization",
                "LocationCity":"Jerusalem",
                "LocationZip":"91120",
                "LocationCountry":"Israel"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"20569537",
                "ReferenceType":"background",
                "ReferenceCitation":"El-Messidi A, Cameron A. Diagnosis of premature rupture of membranes: inspiration from the past and insights for the future. J Obstet Gynaecol Can. 2010 Jun;32(6):561-569. doi: 10.1016/S1701-2163(16)34525-X. Review."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M15882",
                "ConditionBrowseLeafName":"Urinary Incontinence",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6519",
                "ConditionBrowseLeafName":"Enuresis",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}