[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":38,"responsibleParty":146,"collaborators":149,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":10,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":168,"minAge":169,"maxAge":10,"enrollmentInfo":170,"targetDuration":10,"studyType":173,"phases":10,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"The University of New South Wales","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cases",null,"Singleton pregnancies affected by congenital heart disease",[13],"Diagnostic Test: Automated fetal cardiac function evaluation",{"label":15,"type":10,"description":16,"interventionNames":17},"Controls","Singleton healthy pregnancies",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","Automated fetal cardiac function evaluation","Evaluation of ultrasound parameters by automated algorithms.\n\nUltrasound assessed parameters are:\n\n1. Pulsed wave Doppler Modified Left and Right Myocardial performance indices\n2. Spatio-temporal image correlation Tricuspid, Mitral and Septal Annular Plane Systolic Excursion",[9,15],[25,28],{"name":26,"affiliation":5,"role":27},"Anna Erenbourg, MD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":5,"role":30},"Alec W Welsh, MD PhD","STUDY_DIRECTOR",[32,36],{"name":26,"role":33,"phone":34,"phoneExt":10,"email":35},"CONTACT","+61423879866","a.erenbourg@unsw.edu.au",{"name":29,"role":33,"phone":10,"phoneExt":10,"email":37},"alec.welsh@unsw.edu.au",[39,57,72,89,104,119,132],{"facility":40,"status":41,"city":42,"state":43,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Royal Hospital for Women","RECRUITING","Sydney","New South Wales","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],151.20732,-33.86785,{"lat":50,"lon":49},[53,55],{"name":54,"role":33,"phone":10,"phoneExt":10,"email":37},"Alec Welsh",{"name":56,"role":33,"phone":10,"phoneExt":10,"email":35},"Anna Erenbourg",{"facility":58,"status":59,"city":60,"state":10,"zip":10,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Sheba Medical Center","NOT_YET_RECRUITING","Tel Aviv","Israel","IL",{"type":47,"coordinates":64},[65,66],34.78057,32.08088,{"lat":66,"lon":65},[69],{"name":70,"role":33,"phone":10,"phoneExt":10,"email":71},"Hagai Avnet","hagai.Avnet@sheba.health.gov.il",{"facility":73,"status":59,"city":74,"state":10,"zip":10,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"San Salvatore Hospital L'Aquila","L’Aquila","Italy","IT",{"type":47,"coordinates":78},[79,80],13.39954,42.35055,{"lat":80,"lon":79},[83,86],{"name":84,"role":33,"phone":10,"phoneExt":10,"email":85},"Ilaria Fantasia","ilariafantasia@gmail.com",{"name":87,"role":33,"phone":10,"phoneExt":10,"email":88},"Sara tabacco","saratabacco87@gmail.com",{"facility":90,"status":59,"city":91,"state":10,"zip":10,"country":75,"countryCode":76,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Vittore Buzzi Children's Hospital","Milan",{"type":47,"coordinates":93},[94,95],9.18951,45.46427,{"lat":95,"lon":94},[98,101],{"name":99,"role":33,"phone":10,"phoneExt":10,"email":100},"Stefano Faiola","stefanofaiola@hotmail.com",{"name":102,"role":33,"phone":10,"phoneExt":10,"email":103},"Chiara Coco","chiaracoco401@gmail.com",{"facility":105,"status":59,"city":106,"state":10,"zip":10,"country":75,"countryCode":76,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Institute for Maternal and Child Health IRCCS Burlo Garofolo","Trieste",{"type":47,"coordinates":108},[109,110],13.77678,45.64953,{"lat":110,"lon":109},[113,116],{"name":114,"role":33,"phone":10,"phoneExt":10,"email":115},"Tamara Stampalija","tamara.stampalija@burlo.trieste.it",{"name":117,"role":33,"phone":10,"phoneExt":10,"email":118},"Sofia Bussolaro","sofia.bussolaro91@gmail.com",{"facility":120,"status":59,"city":121,"state":10,"zip":10,"country":122,"countryCode":10,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Centre Hospitalier de Mayotte","Mamoudzou","Mayotte",{"type":47,"coordinates":124},[125,126],45.22878,-12.78234,{"lat":126,"lon":125},[129],{"name":130,"role":33,"phone":10,"phoneExt":10,"email":131},"Vera Cecotti","veradott@gmail.com",{"facility":133,"status":59,"city":134,"state":10,"zip":10,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Medical Center Ujastek","Krakow","Poland","PL",{"type":47,"coordinates":138},[139,140],19.93658,50.06143,{"lat":140,"lon":139},[143],{"name":144,"role":33,"phone":10,"phoneExt":10,"email":145},"Beata Radzymińska-Chruściel","bearad63@gmail.com",{"type":147,"investigatorFullName":56,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Consultant in Obstetrics and Gynaecology",[150,151,152,154,156,158],{"name":120,"class":6},{"name":90,"class":6},{"name":153,"class":6},"San Salvatore Hospital of L'Aquila",{"name":105,"class":155},"UNKNOWN",{"name":58,"class":157},"OTHER_GOV",{"name":159,"class":155},"Clinic of Fetal Echocardiography, Medical Centre UJASTEK","100492909","automated-fetal-cardiac-function-in-babies-affected-by-heart-diseases-100492909",false,"NCT05698277","Automated Fetal Cardiac Function in Babies Affected by Heart Diseases","Automated Fetal Cardiac Function Parameters in Congenital Heart Disease","Inclusion Criteria:\n\n* Inclusion criteria for the CHD Group are as follows: singleton pregnancies; gestational age between 19+6 and 36+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; isolated congenital cardiac anomaly diagnosed.\n* Inclusion criteria for the Control Group are as follows: singleton pregnancies; gestational age between 19+6 and 27+6 weeks gestation, determined by the last menstrual period and confirmed by first trimester ultrasound; no congenital cardiac anomaly diagnosed\n\nExclusion Criteria common to the 2 groups (Cases and Controls):\n\n* Fetuses whose mothers have comorbidities that have been proven to potentially affect cardiac function including:\n\n  * intrahepatic cholestasis\n  * pre-gestational and gestational diabetes\n  * preeclampsia\n  * growth restricted fetuses defined as estimated fetal weight or abdominal circumference \\\u003C3rd percentile for GA\n* Fetuses with other structural extracardiac anomalies at ultrasound examination\n* Fetuses affected by any diagnosed genetic abnormalities",true,"FEMALE","18 Years",{"count":171,"type":172},495,"ESTIMATED","OBSERVATIONAL","The goal of this international multicentre prospective observational cohort study with a nested case-control study is to test some automated fetal heart functional parameters in healthy babies compared to those affected by a congenital heart condition.\n\nThe main questions it aims to answer are:\n\n* If there is a significant difference between the two populations of infants\n* Whether these parameters could significantly improve the predictive value of actual cardiovascular profile score to predict hydrops Participants will be offered two automated cardiac function assessments between 27+6 and 29+6 gestational weeks and between 34+6 and 36+6 weeks of gestation. Functional parameters will be compared between the two study groups and evaluated over time.",[176,177],"Congenital Heart Defect","Cardiac Function",[179,180],"Congenital Heart Diseases","Fetal Cardiac Function","2024-12-09",{"date":183,"type":184},"2024-12-10","ACTUAL",{"date":186,"type":184},"2023-05-01",{"date":188,"type":172},"2028-02-01",{"name":56,"class":6},7]