[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629356":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":31,"interventions":37,"overallOfficials":26,"centralContacts":42,"locations":52,"responsibleParty":79,"collaborators":26,"id":83,"slug":26,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":95,"studyType":96,"phases":26,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":55,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Hospital General Universitario Gregorio Marañon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Failed epidural analgesia during labor","Persistence of pain 20 minutes after one top-up bolus of local anesthetic administered by the anesthesiologist, in a previously working epidural analgesia.","All duration of labour (from admission to labour ward until delivery) in patients with an initial adequate pain relief after epidural analgesia initiation.",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Failed onset of epidural block","Absence or insufficient epidural block in level and\u002For density in the first 30 minutes after the administration of the induction bolus.","An incomplete or inefficient block 30 minutes after initiation of epidural analgesia will be considered as a failed onset.",{"measure":19,"description":20,"timeFrame":21},"Failed conversion of epidural analgesia to anesthesia for intrapartum cesarean birth","Requirement for a new regional block, intravenous supplementation or general anesthesia for an intrapartum cesarean birth in a patient with labor epidural analgesia.","In subpopulation of patients with an intrapartum cesarean delivery, failed conversion will be considered for any requirement for intravenous supplementation or general anaesthesia during caesarean delivery.",{"measure":23,"description":24,"timeFrame":25},"Maternal recovery until 48h postpartum","Measurement of maternal recovery at 24 and 48 hours postpartum using the Spanish-validated version of 10-Items Obstetric Quality of Recovery scoring tool (ObsQoR-10).\n\nThis 0-100 points score includes:\n\n* 4 items concerning postpartum side effects, rated from 0 to 10, with higher scores corresponding to lower intensity of side effects,\n* 6 items concerning postpartum recovery variables, rated from 0 to 10, with higher scores corresponding to better postpartum recovery.","On postpartum day 1 (24h after delivery) and day 2 (48h after delivery), during post-partum anaesthesia visit, the participants will answer the 10-Items Obstetric Quality of Recovery scoring tool (ObsQoR-10).",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","Cohort of consecutive consenting patients admitted in the labor ward for delivery of two tertiary university hospitals in Madrid-Spain for a period of 1 month, which each center chooses throughout 2026.",[32],{"label":33,"type":26,"description":34,"interventionNames":35},"Labor Epidural Analgesia","Inclusion criteria: all consecutive patients in labor who request epidural analgesia for labor analgesia in the period of recruitment.\n\nExclusion criteria: parturient age under 18 years; stillbirth; continuous spinal anesthesia; refusal to participate",[36],"Other: No Intervention: Observational Cohort",[38],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":26},"No Intervention: Observational Cohort","No intervention: observational study",[33],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Nicolas Brogly, MD, PhD","CONTACT","+34 663676820","nicolas.brogly@salud.madrid.org",{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},"Francisco Galván-Román, MD","+34 691246504","franciscojesus.galvan@salud.madrid.org",[53,68],{"facility":54,"status":55,"city":56,"state":26,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Hospital General Universitario Gregorio Marañón","RECRUITING","Madrid","28007","Spain","ES",{"type":61,"coordinates":62},"Point",[63,64],-3.70256,40.4165,{"lat":64,"lon":63},[67],{"name":49,"role":45,"phone":50,"phoneExt":26,"email":51},{"facility":69,"status":70,"city":56,"state":26,"zip":26,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Hospital Universitario La Paz","NOT_YET_RECRUITING",{"type":61,"coordinates":72},[63,64],{"lat":64,"lon":63},[75],{"name":76,"role":45,"phone":77,"phoneExt":26,"email":78},"Isabel Valbuena Gómez, MD, PhD","+34 619416458","isa_valbuena_gomez@hotmail.com",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Nicolas Brogly","Coordinator of failing epidural Investigation","100629356",false,"NCT07473609","Failing Epidural Analgesia During Labor","Analysis of the Incidence and Risk Factors of Epidural Analgesia Failure During Labor: A Prospective Multicenter Observational Study","FEA25","Inclusion Criteria:\n\n* Parturient who requests epidural analgesia for labor\n\nExclusion Criteria:\n\n* Age under 18 years\n* Stillbirth\n* Continuous spinal anesthesia\n* Refusal to participate","FEMALE","18 Years",{"count":93,"type":94},500,"ESTIMATED","2 Days","OBSERVATIONAL","This prospective multicenter observational study is being conducted at the Gregorio Marañón University General Hospital and the La Paz University Hospital in Madrid, Spain. The recruitment period began on January 12, 2026, and will continue until February 12, 2027. Patients over 18 years of age requesting epidural analgesia for labor are included. Exclusion criteria are: age under 18; stillbirth; continuous spinal anesthesia; refusal to participate in the study. The primary objective of the study is to calculate the incidence of epidural analgesia failure during labor. Secondary objectives are: identification of potential risk factors for epidural analgesia failure; failure of epidural anesthesia for emergency cesarean birth; maternal postpartum recovery at 24 and 48 hours using the Spanish-validated version of ObsQoR-10 questionnaire.",[99,100],"Failed Epidural Analgesia","Post-partum Recovery",[102,103,104,105,106,107],"Labor analgesia","intrapartum cesarean delivery","failed epidural analgesia","breakthrough pain","epidural catheter re-siting","ObsQoR-10","2026-03-12",{"date":110,"type":111},"2026-03-16","ACTUAL",{"date":113,"type":111},"2026-01-12",{"date":115,"type":94},"2027-02-12",{"name":81,"class":6},2]