[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516876":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":25,"responsibleParty":42,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Visual interpretation of cardiotocography","ACTIVE_COMPARATOR","Monitoring by visual interpretation of cardiotocography",[13],"Device: Visual interpretation",{"label":15,"type":16,"description":17,"interventionNames":18},"Short term variation","EXPERIMENTAL","Short term variation by computer software analysis",[19],"Device: Short term variation",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Short term variation in computer software analysis",[15],null,{"type":22,"name":27,"description":9,"armGroupLabels":28,"otherNames":25},"Visual interpretation",[9],[30],{"name":31,"affiliation":32,"role":33},"Wessel Ganzevoort, MD PhD","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","003120-5669111","j.w.ganzevoort@amsterdamumc.nl",{"name":40,"role":36,"phone":37,"phoneExt":25,"email":41},"Anouk Pels, MD PhD","a.pels@amsterdamumc.nl",{"type":33,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Wessel Ganzevoort","Principal investigator","100516876","stv-analysis-versus-visual-evaluation-of-cardiotocography-in-fgr-100516876",false,"NCT06010238","STV Analysis Versus Visual Evaluation of Cardiotocography in FGR","Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction","SAVEFGR","Inclusion Criteria:\n\n* Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.\n* Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (\\\u003Cp3) OR a combination of EFW \\\u003Cp10 AND uterine artery pulsatility index (PI) \\>p95 OR umbilical artery Doppler PI \\>p95.\n* Maternal age ≥ 18 years.\n* Able to provide written informed consent for collection and use of data on informed consent form in available language.\n\nExclusion Criteria:\n\n* Known congenital or chromosomal anomalies influencing perinatal outcome.\n* Imminent labour or expected maternal indication for delivery \\\u003C 48 hours.","FEMALE","18 Years","99 Years",{"count":57,"type":58},800,"ESTIMATED","INTERVENTIONAL",[61],"NA","This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.",[64],"Fetal Growth Retardation",[66,67,68,69],"fetal growth restriction","cardiotocography","perinatal death","short term variation","NOT_YET_RECRUITING","2024-08-07",{"date":73,"type":74},"2024-08-09","ACTUAL",{"date":76,"type":58},"2025-01-01",{"date":78,"type":58},"2029-01-01",{"name":5,"class":6}]