[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530453":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":41,"locations":50,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":10,"studyType":88,"phases":10,"briefSummary":89,"conditions":90,"keywords":10,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"No maternal epidural labor analgesia",null,"Term infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: No maternal epidural labor analgesia",[13,14,15],"Other: Monitoring with Neobeat heart rate meter","Other: Maternal arterial blood gases","Other: Amniotic fluid lactate",{"label":17,"type":10,"description":18,"interventionNames":19},"With maternal epidural labor analgesia","Term infants monitored with cardiotocography with ST-segment analysis (STAN) during labour: With maternal epidural labor analgesia",[13,14,15],[21,27,31],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Monitoring with Neobeat heart rate meter","At the designated time for cord clamping as per clinical indication, a 10 cm segment of the umbilical cord will be double-clamped and 5 ml of preferably arterial blood will be obtained.\n\nIn infants brought to the resuscitation table, six ECG electrodes will be placed on the skin and cardiac output will be measured with a hemodynamic monitor (PhysioFlow®) for at least 10 min, or until the end of resuscitation\u002Fstabilization.",[9,17],[26],"Umbilical cord blood withdrawal and Monitoring with impedance cardiography",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"Maternal arterial blood gases","Arterial blood gases will be drawn from a radial artery line and analyzed at the end of a contraction at pre-specified time points during labor.",[9,17],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"Amniotic fluid lactate","Amniotic fluid will be collected (2mL) and analyzed at pre-specified time points after rupture of the membranes.",[9,17],[36,39],{"name":37,"affiliation":5,"role":38},"Åsa Waldum, PhD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":38},"Anne Lee Solevåg, MD, PhD",[42,46],{"name":40,"role":43,"phone":44,"phoneExt":10,"email":45},"CONTACT","+4741469314","a.l.solevag@medisin.uio.no",{"name":47,"role":43,"phone":48,"phoneExt":10,"email":49},"Kathrine Samuelsen Hansen, MSc","+4791711476","kathrine_samuelsen@hotmail.com",[51],{"facility":5,"status":52,"city":53,"state":10,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Oslo","0424","Norway","NO",{"type":58,"coordinates":59},"Point",[60,61],10.74609,59.91273,{"lat":61,"lon":60},[64,66],{"name":40,"role":43,"phone":44,"phoneExt":10,"email":65},"lans@ous-hf.no",{"name":37,"role":43,"phone":67,"phoneExt":10,"email":68},"+4748261713","awaldum@ous-hf.no",{"type":38,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Anne Lee Solevåg","Consultant physician",[73],{"name":74,"class":6},"South-Eastern Norway Regional Health Authority","100530453","fetal-assessment-of-the-myocardium-and-evaluation-of-the-neonate-100530453",false,"NCT06186973","Fetal Assessment of the Myocardium and Evaluation of the Neonate","FAME-n","Inclusion Criteria:\n\nWomen admitted for labor and newborn infants will be included after written consent from both parents (if applicable). The final inclusion criterion is that CTG with STAN is used for fetal surveillance at clinician's discretion.\n\nExclusion Criteria:\n\nPerinatal asphyxia fulfilling the criteria for therapeutic hypothermia, major malformations and stillbirth, known chromosomal anomalies or congenital heart defects other than a patent ductus arteriosus.","ALL","0 Hours","1 Hour",{"count":86,"type":87},220,"ESTIMATED","OBSERVATIONAL","FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal asphyxia-related illness and death. Neonatal hemodynamics may be improved by early detection of instability of the heart and circulation. Innovative use of technology enables characterization of normal and abnormal cardiovascular transition in a significantly larger number of fetuses and newborn infants than what was previously possible. The methods used may have broad generalizability and applicability in perinatal, neonatal and pediatric medicine.\n\nIn September 2023, the project was expanded with an obstetric arm called Epidural analgesia: Fetal Oxygenation and Maternal Oxygenation (Epi-FOMO). In Epi-FOMO, the relationship between maternal breathing and arterial blood gases during labour, and umbilical cord blood gases and neonatal outcomes (as specified in FAME-n) will be investigated.",[91,92,93,94,95],"Newborn Asphyxia","Hemodynamic Instability","Myocardium; Ischemic","Fetal Distress","Labor Pain","2025-03-17",{"date":98,"type":99},"2025-03-18","ACTUAL",{"date":101,"type":99},"2022-11-14",{"date":103,"type":87},"2035-12-31",{"name":5,"class":6},1]