[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594093":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":10,"centralContacts":23,"locations":29,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":67,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exposed",null,"Children prenatally exposed to labour epidural analgesia",[13],"Procedure: Labour epidural analgesia",{"label":15,"type":10,"description":16,"interventionNames":10},"Unexposed","Prenatally not exposed to labour epidural analgesia",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"PROCEDURE","Labour epidural analgesia","Prenatal exposure to labour epidural analgesia during delivery",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Tom Bleeser, MD, PhD","CONTACT","+3216344270","tom.bleeser@uzleuven.be",[30],{"facility":31,"status":10,"city":32,"state":10,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"University Hospitals Leuven","Leuven","3000","Belgium","BE",{"type":37,"coordinates":38},"Point",[39,40],4.70093,50.87959,{"lat":40,"lon":39},[43],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100594093","intelligence-and-neurodevelopmental-outcome-after-prenatal-exposure-to-labour-epidural-analgesia-a-sibling-matched-clinical-ambidirectional-cohort-study-100594093",false,"NCT07014956","Intelligence and Neurodevelopmental Outcome After Prenatal Exposure to Labour Epidural Analgesia: a Sibling Matched Clinical Ambidirectional Cohort Study","Inclusion Criteria:\n\n* Exposed children: Children prenatally exposed to labour epidural analgesia\n* Unexposed children: Sibling of an exposed child, Prenatally not exposed to labour epidural analgesia\n* Exposed \\& unexposed children: Children born from 1st January 2014 until 1st November 2019, Parental informed consent\n\nExclusion Criteria:\n\n* Children whose mothers underwent maternal surgery or foetal surgery\u002Finterventions during the same pregnancy.\n* Children exposed to general anaesthesia after birth\n* Children prenatally exposed to chemotherapy, radiotherapy, radiology, oncologic pathology\n* Children born at a gestational age \\\u003C 37 weeks or \\> 42 weeks, or with a birth weight \\\u003C 2.5 kg\n* Twins, triplets, multiple births\n* No Dutch-speaking children\n* Diagnosis of severe disability of genetic origin (e.g., Fragil X, Down syndrome,…), history of head trauma, major congenital birth defects\n* Elective caesarean section and intrapartum caesarean section (the number of caesarean sections will be reported and compared between both groups)\n* Foetus died before start of delivery",true,"ALL","6 Years","16 Years",{"count":57,"type":58},128,"ESTIMATED","OBSERVATIONAL","In Belgium, labour epidural analgesia (LEA) has been used for decades in the vast majority of vaginal deliveries (up to 83% of deliveries). Labour epidural analgesia is the most effective and safest way to allow pregnant women a nearly pain-free labour- and birth experience. Recent data showed that the use of LEA was associated with a reduced risk for severe maternal morbidity, neonatal resuscitation and with a reduced risk for low Apgar scores. However, prenatal exposure to labour epidural analgesia has been associated by several study groups with an increased risk for autism spectrum disorder (ASD) in the children, but these studies suffer from several important limitations which may have induced significant bias (e.g., not correcting for unmeasured confounders). Associations with other neurodevelopmental disorders (e.g., Attention Deficit Hyperactivity Disorder (ADHD), oppositional defiant disorder (ODD) and conduct disorder (CD)) and cognitive functioning have not been investigated yet. There is hence an urgent need for a study allowing definitive conclusions by overcoming the limitations of the previous studies. The investigators will perform the first sibling-matched clinical cohort study using a prospective investigator-assessment of multiple domains of cognitive functions. The investigators hypothesize that prenatal exposure to LEA will neither be associated with reduced intelligence nor with more neurodevelopmental disorders. Validating this hypothesis holds the potential to grant women the assurance to confidently receive the most efficacious method for labour analgesia, free from apprehension that it might have adverse implications for their children's neurodevelopment.",[62,63],"Pregnancy","Epidural Analgesia, Obstetric",[20,65,66],"Neurodevelopmental outcome","Intelligence","NOT_YET_RECRUITING","2025-06-02",{"date":70,"type":71},"2025-06-11","ACTUAL",{"date":73,"type":58},"2025-09-01",{"date":75,"type":58},"2028-09-01",{"name":5,"class":6},1]