{
  "FullStudy":{
    "Rank":217636,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518816",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ABDO-0100"
          },
          "Organization":{
            "OrgFullName":"Ain Shams Maternity Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Role of Serum Total Antioxidant Level in Preterm Labor",
          "OfficialTitle":"the Role of Serum Total Antioxidant Level in Preterm Labor"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 24, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 26, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 30, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Abdallah Salah Abdelatif",
            "ResponsiblePartyInvestigatorTitle":"THE ROLE OF SERUM TOTAL ANTI OXIDANT IN PRETERM LABOR",
            "ResponsiblePartyInvestigatorAffiliation":"Ain Shams Maternity Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ain Shams Maternity Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to detect the association between maternal serum antioxidant level and preterm labor.",
          "DetailedDescription":"Study design:\n\nThis is a prospective case-control study.\n\nSetting:\n\nThe study will be conducted at Ain Shams University Maternity Hospital.\n\nPopulation of the study:\n\nA total of 70 pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.\n\nPatient will be divided in to two groups. Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation < 2cm and effacement< 50%) which will deliver within one week maximum after hospitalization.\n\nGroup B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit.\n\nEvery case will be subjected to:-\n\nWritten informed consent before the study.\nComplete history .\nComplete general and abdominal examination.\nInfection markers(CRP,WBCs count, urine analysis ).\nGestational age determination by the last menstrual date or Ultrasonography.\nLocal pelvic examination."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Preterm Labor"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "antioxidant preterm labor"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"None Retained",
            "BioSpecDescription":"serum"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"70",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"preterm labor cases",
                "ArmGroupDescription":"Group A: 35 pregnant women diagnosed with preterm labor(Preterm labor pain at least 3 contraction every 20 minutes ,cervical dilatation < 2cm and effacement< 50%) which will deliver within one week maximum after hospitalization."
              },{
                "ArmGroupLabel":"control group",
                "ArmGroupDescription":"Group B: 35 pregnant women( controls )with uncomplicated pregnancies at a similar gestational ages followed routinely in the antenatal care unit."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPreterm labor(pregnant between 28th and 37th week).\nSingleton pregnancy.\nAmnion membranes were intact\n\nExclusion Criteria:\n\nPast history of preterm labor or premature delivery.\nUrinary tract infections and any other infections.\nPoly- or oligohydramnios.\nFetal distress, fetal or uterine anomaly.\nMembranes rupture and placenta pathology.\nPreeclampsia or intrauterine growth retardation",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"pregnant women attending the outpatient obstetric clinic and inpatient of Obstetrics and Gynecology department or when they will be admitted to the delivary room of Ain Shams university hospital.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Mohamed SE elsafty, lecturer",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"01003922211",
                "CentralContactPhoneExt":"002"
              },{
                "CentralContactName":"Ahmed M Ibrahim, ass proff",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"01223416828",
                "CentralContactPhoneExt":"002",
                "CentralContactEMail":"abugooda@hotmail.com"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"ABDALLAH s ABDELATIF, residant",
                "OverallOfficialAffiliation":"Ain Shams Maternity Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Ain Shams Maternity Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Cairo",
                "LocationState":"Tertiary",
                "LocationCountry":"Egypt",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Abdallah s Abdelatif, residant",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"01149013302",
                      "LocationContactPhoneExt":"002",
                      "LocationContactEMail":"dr.abdallah_salah@yahoo.com"
                    },{
                      "LocationContactName":"Mohamed SE Elsafty, lecturer",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"01003922211",
                      "LocationContactPhoneExt":"002"
                    },{
                      "LocationContactName":"Abdallah S Abdelatif, residant",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000047928",
                "ConditionMeshTerm":"Premature Birth"
              },{
                "ConditionMeshId":"D000007752",
                "ConditionMeshTerm":"Obstetric Labor, Premature"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000007744",
                "ConditionAncestorTerm":"Obstetric Labor Complications"
              },{
                "ConditionAncestorId":"D000011248",
                "ConditionAncestorTerm":"Pregnancy Complications"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M24456",
                "ConditionBrowseLeafName":"Premature Birth",
                "ConditionBrowseLeafAsFound":"Preterm",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9355",
                "ConditionBrowseLeafName":"Obstetric Labor, Premature",
                "ConditionBrowseLeafAsFound":"Preterm Labor",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9347",
                "ConditionBrowseLeafName":"Obstetric Labor Complications",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12710",
                "ConditionBrowseLeafName":"Pregnancy Complications",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}