[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553086":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":24,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":76,"whyStopped":24,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"group A (FRI)","ACTIVE_COMPARATOR","The \"Fetal Reserve Index\" algorithm will be applied to the first group of patients. In in these patients the fetal reserve index will be calculated every 10 minutes.. For patients with abnormal FRI a 40 minute timer will be started within which it will be necessary to exit the \"red zone\". If such patients will not be able to exit the red zone within 40 minutes, an additional timer will be started of 30 minutes within which the birth will be completed.",[13],"Other: Interpretation of the CTG using FRI score",{"label":15,"type":10,"description":16,"interventionNames":17},"group B (No FRI)","The second group of patients will, however, be managed according to the usual protocols internal management.",[18],"Other: Classic interpretation of the CTG",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Interpretation of the CTG using FRI score","At each of the components of the score will be assigned a score of 1 if the variable evaluated is considered normal, 0 if classified as abnormal. To encourage a simplified clinical interpretation of the different scores obtained (score from 1 to 8) they will be classified into 3 risk categories: Score 5-8: green zone, Score 3-4: zone yellow, Score 1-2: red zone. An FRI of 1-2 (red zone) is to be considered as anomalous",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Classic interpretation of the CTG","evaluate the CTG of group B patients according to the usual internal management protocols",[15],[30],{"name":31,"affiliation":5,"role":32},"Angela BOTTA","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","0630157024","angela.botta@policlinicogemelli.it",[39],{"facility":40,"status":24,"city":41,"state":24,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Fondazione Policlinico Universitario A. Gemelli IRCCS","Roma","00168","Italy","IT",{"type":46,"coordinates":47},"Point",[48,49],11.10642,44.99364,{"lat":49,"lon":48},[52,55],{"name":53,"role":35,"phone":54,"phoneExt":24,"email":37},"Angela Botta","+390630157024",{"name":53,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100553086","fri-a-method-of-reading-cardiotocography-ctg-in-labor-100553086",false,"NCT06481514","FRI a Method of Reading Cardiotocography (CTG) in Labor","Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.","FINIS","Inclusion Criteria:\n\n* Women in the active phase of labor who presented when they entered the room I delivered a negative admission test (i.e. a normoreactive CTG according to ACOG) and that subsequently present during labor a diagnosis of category II CTG\n* Single term pregnancy\n* Signature of informed consent\n\nExclusion criteria\n\n* Failure to sign the informed consent\n* Previous caesarean section (TOLAC)\n* Twin pregnancy\n* Gestational age \\\u003C37 weeks\n* Known genetic\u002Fchromosomal syndromes and\u002For malformations, excluding heart disease without contraindication to vaginal birth\n\nExclusion Criteria:\n\n\\-","FEMALE",{"count":68,"type":69},290,"ESTIMATED","INTERVENTIONAL",[72],"NA","The objective of the study is to investigate the FRI's ability to identify cases requiring urgent intervention which will present an adverse perinatal outcome (respiratory acidosis, metabolic acidosis, Apgar index, etc.) compared to the classical interpretation of CTG.\n\nPatients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups. The \"Fetal Reserve Index\" algorithm will be applied to the first group of patients.\n\nThe second group of patients will, however, be managed according to the usual protocols internal management.",[75],"Labor Complication","NOT_YET_RECRUITING","2024-06-25",{"date":79,"type":80},"2024-07-01","ACTUAL",{"date":82,"type":69},"2024-07",{"date":84,"type":69},"2025-12",{"name":5,"class":6},1]