[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":38,"responsibleParty":142,"collaborators":145,"id":156,"slug":10,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":10,"eligibilityCriteria":161,"healthyVolunteers":162,"sex":163,"minAge":164,"maxAge":10,"enrollmentInfo":165,"targetDuration":10,"studyType":168,"phases":10,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"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",[39,56,70,86,101,116,129],{"facility":40,"status":41,"city":42,"state":43,"zip":10,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Royal Hospital for Women","RECRUITING","Sydney","New South Wales","Australia",{"type":46,"coordinates":47},"Point",[48,49],151.20732,-33.86785,{"lat":49,"lon":48},[52,54],{"name":53,"role":33,"phone":10,"phoneExt":10,"email":37},"Alec Welsh",{"name":55,"role":33,"phone":10,"phoneExt":10,"email":35},"Anna Erenbourg",{"facility":57,"status":58,"city":59,"state":10,"zip":10,"country":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Sheba Medical Center","NOT_YET_RECRUITING","Tel Aviv","Israel",{"type":46,"coordinates":62},[63,64],34.78057,32.08088,{"lat":64,"lon":63},[67],{"name":68,"role":33,"phone":10,"phoneExt":10,"email":69},"Hagai Avnet","hagai.Avnet@sheba.health.gov.il",{"facility":71,"status":58,"city":72,"state":10,"zip":10,"country":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"San Salvatore Hospital L'Aquila","L’Aquila","Italy",{"type":46,"coordinates":75},[76,77],13.39954,42.35055,{"lat":77,"lon":76},[80,83],{"name":81,"role":33,"phone":10,"phoneExt":10,"email":82},"Ilaria Fantasia","ilariafantasia@gmail.com",{"name":84,"role":33,"phone":10,"phoneExt":10,"email":85},"Sara tabacco","saratabacco87@gmail.com",{"facility":87,"status":58,"city":88,"state":10,"zip":10,"country":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Vittore Buzzi Children's Hospital","Milan",{"type":46,"coordinates":90},[91,92],9.18951,45.46427,{"lat":92,"lon":91},[95,98],{"name":96,"role":33,"phone":10,"phoneExt":10,"email":97},"Stefano Faiola","stefanofaiola@hotmail.com",{"name":99,"role":33,"phone":10,"phoneExt":10,"email":100},"Chiara Coco","chiaracoco401@gmail.com",{"facility":102,"status":58,"city":103,"state":10,"zip":10,"country":73,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Institute for Maternal and Child Health IRCCS Burlo Garofolo","Trieste",{"type":46,"coordinates":105},[106,107],13.77678,45.64953,{"lat":107,"lon":106},[110,113],{"name":111,"role":33,"phone":10,"phoneExt":10,"email":112},"Tamara Stampalija","tamara.stampalija@burlo.trieste.it",{"name":114,"role":33,"phone":10,"phoneExt":10,"email":115},"Sofia Bussolaro","sofia.bussolaro91@gmail.com",{"facility":117,"status":58,"city":118,"state":10,"zip":10,"country":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Centre Hospitalier de Mayotte","Mamoudzou","Mayotte",{"type":46,"coordinates":121},[122,123],45.22878,-12.78234,{"lat":123,"lon":122},[126],{"name":127,"role":33,"phone":10,"phoneExt":10,"email":128},"Vera Cecotti","veradott@gmail.com",{"facility":130,"status":58,"city":131,"state":10,"zip":10,"country":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Medical Center Ujastek","Krakow","Poland",{"type":46,"coordinates":134},[135,136],19.93658,50.06143,{"lat":136,"lon":135},[139],{"name":140,"role":33,"phone":10,"phoneExt":10,"email":141},"Beata Radzymińska-Chruściel","bearad63@gmail.com",{"type":143,"investigatorFullName":55,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Consultant in Obstetrics and Gynaecology",[146,147,148,150,152,154],{"name":117,"class":6},{"name":87,"class":6},{"name":149,"class":6},"San Salvatore Hospital of L'Aquila",{"name":102,"class":151},"UNKNOWN",{"name":57,"class":153},"OTHER_GOV",{"name":155,"class":151},"Clinic of Fetal Echocardiography, Medical Centre UJASTEK","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":166,"type":167},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.",[171,172],"Congenital Heart Defect","Cardiac Function",[174,175],"Congenital Heart Diseases","Fetal Cardiac Function","2024-12-09",{"date":178,"type":179},"2024-12-10","ACTUAL",{"date":181,"type":179},"2023-05-01",{"date":183,"type":167},"2028-02-01",{"name":55,"class":6},7]