[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560226":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":19,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":19,"enrollmentInfo":58,"targetDuration":19,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Childhood neurodevelopment","EXPERIMENTAL","Newborns from mothers with congenital heart disease will be subjected to neurodevelopmental assessment",[13],"Diagnostic Test: Neurodevelopmental assessment",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","Neurodevelopmental assessment",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Massimo Massetti","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Grandinetti Maria","CONTACT","+39 3478555745\u002F 0630154241","maria.grandinetti@policlinicogemelli.it",[31],{"facility":32,"status":19,"city":33,"state":19,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Fondazione universitaria policlinico Agostino Gemelli","Roma","00168","Italy","IT",{"type":38,"coordinates":39},"Point",[40,41],11.10642,44.99364,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":19,"phoneExt":19,"email":29},"Maria Grandinetti",{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100560226","pregnancy-in-guch-patients-100560226",false,"NCT06574386","Pregnancy in GUCH Patients","Pregnancy in GUCH Patients: Maternal-Foetal-Neonatal Aspects at Mid Term","PURE-HEART","Inclusion Criteria:\n\n* Congenital heart disease in natural history or undergoing corrective and\u002For palliative cardiothoracic surgery.\n* Chronological age \\> 18 years.\n* Single pregnancy progressing normally at a gestational age of 14 weeks + 0.\n* Correct pregnancy dating based on CRL as per ISUOG guidelines. (26)\n* Normal results of non-invasive screening tests for foetal aneuploidies.\n* Normal first-trimester ultrasound examination.\n* Informed consent of the woman.\n\nExclusion Criteria:\n\n* Maternal chromosomal abnormalities.\n* Maternal syndromic conditions.\n* Spontaneous abortion.\n* Vanishing Twin.\n* High risk for chromosomal abnormalities on screening tests performed in the 1st Trimester (Combined Test\u002FNIPT) or Major foetal structural anomalies identified during first-trimester ultrasound evaluation.","FEMALE","18 Years",{"count":59,"type":60},70,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study aims to investigate the impact of congenital heart diseases on maternal and foetal-neonatal health, the effect of pregnancy on maternal cardiac health, and the outcome of newborns\u002Fchildren born from Grown-Up Congenital Heart (GUCH) mothers with follow-up at one year, extendable to two.\n\nThe main question it aims to answer is:\n\n-Does maternal congenital heart disease affects outcomes of newborn?",[66,67,68,69,70],"Congenital Heart Disease","Pregnancy Related","Infant Development","IUGR","Fetal Growth Restriction",[72,73],"GUCH","Pregnancy","NOT_YET_RECRUITING","2024-10-18",{"date":77,"type":78},"2024-10-22","ACTUAL",{"date":80,"type":60},"2024-11-01",{"date":82,"type":60},"2029-10-01",{"name":5,"class":6},1]