Nctid:
NCT06612320
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M14106", "name"=>"Pre-Eclampsia", "relevance"=>"LOW"}, {"id"=>"M7633", "name"=>"Eclampsia", "relevance"=>"LOW"}, {"id"=>"T2019", "name"=>"Eclampsia", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>720}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-06", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Collection of maternal demographic characteristics", "timeFrame"=>"Day 1", "description"=>"Age, level of education, profession, geographic origin, health insurance/mutual, marital status The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.\n\nNo score, it is a qualitative analyse."}, {"measure"=>"Collection of obstetric characteristics", "timeFrame"=>"Day 1", "description"=>"Parity, obstetric history (first-trimester pregnancy loss, IUFD, perinatal death), pregnancy complications, gestational age... The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.\n\nNo score, it is a qualitative analyse."}, {"measure"=>"Collection of characteristics related to information provided", "timeFrame"=>"Day 1", "description"=>"By whom? , with whom? (impact of the companion), when? The primary objective is to assess whether there are factors associated with women's refusal to participate in randomized clinical trials.\n\nNo score, it is a qualitative analyse."}], "secondaryOutcomes"=>[{"measure"=>"Motivation linked to acceptance", "timeFrame"=>"Day 1", "description"=>"Evaluation of motivation linked to acceptance (based on the questionnaire given to women who agree to participate).\n\nNo score, it is a qualitative analyse."}, {"measure"=>"Reason for refusing to participate", "timeFrame"=>"Day 1", "description"=>"Evaluation of the reason for refusing to participate (based on the questionnaire given to women who refuse to participate)\n\nNo score, it is a qualitative analyse."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Refusal", "clinical trial", "factors", "reasons", "pregnancy", "pre-eclampsia"], "conditions"=>["Pregnancy Related"]}, "descriptionModule"=>{"briefSummary"=>"The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving pregnancy and childbirth in France. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.", "detailedDescription"=>"1. Determine the acceptance/refusal rate among all women identified, eligible and offered RCT.\n2. Comparison of demographic characteristics between the two groups\n\n * Group 1: women accepting to participate in RCT\n * Group 2: women refusing to participate in RCT\n3. Assessment of motivations for acceptance (based on questionnaire given to women who agree to participate)\n4. Evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"The study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nThe study will be offered to all women who have been offered to participate in a randomized trial relating to their pregnancy and/or childbirth in participating services.\n\nExclusion Criteria:\n\nNone"}, "identificationModule"=>{"nctId"=>"NCT06612320", "acronym"=>"REFWIT", "briefTitle"=>"Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance", "organization"=>{"class"=>"OTHER", "fullName"=>"Assistance Publique - Hôpitaux de Paris"}, "officialTitle"=>"Refusal to Participate in a Randomized Trial Involving Pregnancy and Childbirth: Factors Associated with Refusal and Reasons for Refusal and Acceptance", "orgStudyIdInfo"=>{"id"=>"APHP240778"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Acceptance", "description"=>"Women who accept to participate to a Randomized Controlled Trial (RCT)", "interventionNames"=>["Behavioral: Questionnaire about acceptance"]}, {"label"=>"Refusal", "description"=>"Women who refuse to participate to a Randomized Controlled Trial (RCT)", "interventionNames"=>["Behavioral: Questionnaire about refusal"]}], "interventions"=>[{"name"=>"Questionnaire about acceptance", "type"=>"BEHAVIORAL", "description"=>"Questionnaire about acceptance", "armGroupLabels"=>["Acceptance"]}, {"name"=>"Questionnaire about refusal", "type"=>"BEHAVIORAL", "description"=>"Questionnaire about refusal", "armGroupLabels"=>["Refusal"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75014", "city"=>"Paris", "state"=>"IDF", "country"=>"France", "facility"=>"Port-Royal Maternity", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}], "centralContacts"=>[{"name"=>"Yoann ATHIEL, MD", "role"=>"CONTACT", "email"=>"yoann.athiel@aphp.fr", "phone"=>"0158414363"}, {"name"=>"Marie Benhammani-Godard", "role"=>"CONTACT", "email"=>"marie.godard@aphp.fr", "phone"=>"0158411190"}], "overallOfficials"=>[{"name"=>"Yoann Athiel, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Port-Royal Maternity - APHP"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assistance Publique - Hôpitaux de Paris", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
