Nctid:
NCT06224946
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011225", "term"=>"Pre-Eclampsia"}, {"id"=>"D000004461", "term"=>"Eclampsia"}], "ancestors"=>[{"id"=>"D000046110", "term"=>"Hypertension, Pregnancy-Induced"}, {"id"=>"D000011248", "term"=>"Pregnancy Complications"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M14106", "name"=>"Pre-Eclampsia", "asFound"=>"Pre-Eclampsia", "relevance"=>"HIGH"}, {"id"=>"M7633", "name"=>"Eclampsia", "asFound"=>"Eclampsia", "relevance"=>"HIGH"}, {"id"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M25635", "name"=>"Hypertension, Pregnancy-Induced", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"T2019", "name"=>"Eclampsia", "asFound"=>"Eclampsia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008934", "term"=>"Mitogens"}], "ancestors"=>[{"id"=>"D000050258", "term"=>"Mitosis Modulators"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M11900", "name"=>"Mitogens", "asFound"=>"Later", "relevance"=>"HIGH"}, {"id"=>"T22", "name"=>"Tyrosine", "asFound"=>"Wire", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>314}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2021-01-27", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-09", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-01-27", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio", "timeFrame"=>"day 1", "description"=>"Evaluate the impact of the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio on medical decision-making in women with suspected preeclampsia in routine medical care."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pre-Eclampsia", "Placental Growth Factor", "Soluble fms-like tyrosine Kinase", "medical Care decision"], "conditions"=>["Pre-Eclampsia"]}, "descriptionModule"=>{"briefSummary"=>"Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.\n\nThis is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. Values were measured using the Elecsys sFlt-1/PlGF immunoassay ratio. The aim of the study is to observe the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"314 patients were included: 217 women under 37 weeks of gestation age and 97 women above this age.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* pregnant patients over 24 weeks of amenorrhea\n* aged 18 and over\n* with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmHg in diastolic pressure over 2 measurements at 4 hours intervals) OR proteinuria (≥ 0.3 g per 24 hours).\n* who systematically gave oral consent after submitting the information sheet\n\nExclusion Criteria:\n\n* pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia.\n* receiving antihypertensive treatment before pregnancy\n* or refusing to participate in the study The sFlt-1/PlGF ratio was measured only when clinically indicated as per the investigator's judgment."}, "identificationModule"=>{"nctId"=>"NCT06224946", "briefTitle"=>"IMPACT OF THE BIOLOGICAL RATIO ON MEDICAL DECISION MAKING IN WOMEN SUSPECTED OF PREECLAMPSIA", "organization"=>{"class"=>"OTHER", "fullName"=>"Centre Hospitalier Universitaire de Saint Etienne"}, "officialTitle"=>"IMPACT OF THE SOLUBLE LIKE TYROSINE KINASE/PLACENTAL GROWTH FACTOR RATIO ON MEDICAL DECISION-MAKING AND ON MATERNAL AND NEONATAL OUTCOMES IN WOMEN SUSPECTED OF PREECLAMPSIA", "orgStudyIdInfo"=>{"id"=>"CEROG 2022-OBS-0401"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"women under 37 weeks of gestation age", "description"=>"217 women under 37 weeks of gestation age", "interventionNames"=>["Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio"]}, {"label"=>"women above 37 weeks of gestation age", "description"=>"97 women above 37 weeks of gestation age", "interventionNames"=>["Diagnostic Test: soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio"]}], "interventions"=>[{"name"=>"soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio", "type"=>"DIAGNOSTIC_TEST", "description"=>"the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio for pre-eclampsia diagnostic", "armGroupLabels"=>["women above 37 weeks of gestation age", "women under 37 weeks of gestation age"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"42055", "city"=>"Saint-Étienne", "country"=>"France", "facility"=>"Chu Saint-Etienne", "geoPoint"=>{"lat"=>45.43389, "lon"=>4.39}}], "overallOfficials"=>[{"name"=>"BARJAT Tiphaine, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"CHU DE SAINT-ETIENNE"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Centre Hospitalier Universitaire de Saint Etienne", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
