Nctid:
NCT06225557
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"HEALTH_SERVICES_RESEARCH", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"follow ERAS society guidelines recommendations in elective CESAREAN SECTION"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>106}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-03", "studyFirstSubmitDate"=>"2024-01-02", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-05", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Obstetric Quality of Recovery 11 score (ObsQoR-11)", "timeFrame"=>"before discharge or during 24 hour postoperatively", "description"=>"it is consisted of 11 questions covers four domains of recovery outcomes: physical comfort, emotional state, physical independence and care of the neonate, and pain ,each question taking score from 0 to 10 with 0 is the minimum score and 10 is the highest score and the maximum total score is 110 and the minimum total is 0 which is the worest quality of recovery"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["ERAS"]}, "descriptionModule"=>{"briefSummary"=>"The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.", "detailedDescription"=>"The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.\n\nSecondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.\n\nExclusion Criteria:\n\n* -Age less than 18 years\n* Complications (wound infection, re-exploration, caesarean hysterectomies)\n* Recent documented use of opioids Allergy to any drug used during the study.-\n* Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.\n* uncontrolled diabetic patient\n* Severe liver and kidney diseases\n* Coagulation defect"}, "identificationModule"=>{"nctId"=>"NCT06225557", "acronym"=>"ERACS", "briefTitle"=>"Comparison of Outcome Between (ERACS) Versus Traditional Methods in Elective CS", "organization"=>{"class"=>"OTHER", "fullName"=>"Minia University"}, "officialTitle"=>"Comparison of Outcome Between the Implementation of Enhanced Recovery After Elective Cesarean Section Protocol (ERACS) Versus Traditional Methods", "orgStudyIdInfo"=>{"id"=>"383/08/2022"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"ERAS society guidlines", "description"=>"The ERAS society guidelines for elective cesarean section will be followed.", "interventionNames"=>["Other: ERAS community recommendation"]}, {"type"=>"EXPERIMENTAL", "label"=>"Traditional methods", "description"=>"Traditional methods in postoperative care for elective cesarean section will be followed.", "interventionNames"=>["Other: Traditional postoperative care"]}], "interventions"=>[{"name"=>"ERAS community recommendation", "type"=>"OTHER", "description"=>"Enhanced recovery techniques including opioid sparing anesthesia in elective cesarean section", "armGroupLabels"=>["ERAS society guidlines"]}, {"name"=>"Traditional postoperative care", "type"=>"OTHER", "description"=>"Usual anesthesia and analgesia in elective cesarean section.", "armGroupLabels"=>["Traditional methods"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Marwa AA Mohamed, AS Lecturer", "role"=>"CONTACT", "email"=>"marwaelhelaly@hotmail.com", "phone"=>"00201005431155"}, {"name"=>"Haidy SM Mansour, AS professor", "role"=>"CONTACT", "email"=>"haydi.mansour@mu.edu.eg", "phone"=>"00201221802324"}], "overallOfficials"=>[{"name"=>"Ahmad EZ Mahran, professor", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Faculty of Medicine, Minia University"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Minia University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant lecturer", "investigatorFullName"=>"Marwa Abdelrehim Attia Mohamed", "investigatorAffiliation"=>"Minia University"}}}}
