[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609203":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":80,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SOFI group",null,"Women with a CTG trace suspicious for fetal infection\u002Finflammation",[13],"Other: blood sampling",{"label":15,"type":10,"description":16,"interventionNames":17},"NEFI group","Women with normal CTG tracings and no signs of inflammation.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"blood sampling","The study involves the collection of an additional aliquot of cord blood and an additional aliquot of maternal venous blood.",[15,9],[24],{"name":25,"affiliation":5,"role":26},"Elvira Di Pasquo","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+39 0630155989","elvira.dipasquo@policlinicogemelli.it",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Laura Naccarato","+39 3480865246","laura.naccarato94@gmail.com",[37],{"facility":38,"status":10,"city":39,"state":40,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Policlinico Gemelli","Roma","RM","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],11.10642,44.99364,{"lat":47,"lon":46},[50],{"name":25,"role":29,"phone":30,"phoneExt":10,"email":31},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100609203","il-6-and-lactates-in-cord-blood-and-neonatal-outcomes-100609203",false,"NCT07211503","IL-6 and Lactates in Cord Blood and Neonatal Outcomes","Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern","ECCO-IL6","Inclusion Criteria:\n\nSOFI case group:\n\n* Women with gestational age \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation\n* Age ≥18 years\n* Presence of CTG characteristics associated with fetal inflammation\u002Finfection (fetal heart rate (fetal heart rate (FHR) \\>150 bpm with gestational age \\>40 weeks or a 10% increase in FHR, absence of cycling, fetal tachycardia \\>=160 bpm, variability \\\u003C5 bpm)\n* Signed informed consent form by the patient.\n\nNEFI control group:\n\n* Women with gestation \\>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.\n* Single fetus in cephalic presentation.\n* Age ≥18 years.\n* Patients with a CTG tracing that does not show features associated with fetal inflammation\u002Finfection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm).\n* Patient signed informed consent form.\n\nExclusion Criteria:\n\n* Failure to sign informed consent\n* Intrauterine fetal death\n* Congenital fetal and\u002For chromosomal abnormalities\n* Maternal cardiac abnormalities and\u002For cardiac therapy and\u002For therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin)\n* Twin or multiple pregnancy",true,"FEMALE","18 Years",{"count":65,"type":66},160,"ESTIMATED","OBSERVATIONAL","The goal of this observational study or clinical trial is to evaluate interleukin-6 (IL-6) and lactate levels in maternal and cord blood to identify early signs of fetal inflammation or infection.\n\nTwo groups of women with full-term pregnancies will be compared: • Case group (SOFI): women with a cardiotocograph (CTG) pattern suspicious for fetal infection\u002Finflammation • Control group (NEFI): women with a normal cardiotocograph (CTG) pattern without signs of inflammation. The primary outcome is to evaluate whether IL-6 levels detected in the umbilical artery, alone or in combination with maternal IL-6 values, are associated with a cardiotocograph (CTG) pattern suggestive of fetal inflammation and\u002For a clinical picture suggestive of chorioamnionitis. Identifying a possible correlation between IL-6\u002Flactate levels and fetal inflammatory status could facilitate more timely treatment of at-risk infants in the future, contributing to the reduction of adverse outcomes both in the neonatal period and in the long-term.\n\nSecondary outcome are: -Comparison of fetal and maternal IL-6 levels between infants with a composite adverse outcome; - Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.",[70,71,72,73],"Fetal Infection","Fetal Inflammatory Response Syndrome","Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn",[75,76,77,78,79],"il6","chorioamnionitis","FIRS","lactates","labour","NOT_YET_RECRUITING","2025-09-30",{"date":83,"type":84},"2025-10-08","ACTUAL",{"date":86,"type":66},"2025-10-01",{"date":88,"type":66},"2027-04-30",{"name":5,"class":6},1]