[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fetal-inflammatory-response-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fetal-inflammatory-response-syndrome":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},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.",[25,26,27,28],"Fetal Infection","Fetal Inflammatory Response Syndrome","Chorioamnionitis","Chorioamnionitis Affecting Fetus or Newborn",[30,31,32,33,34],"il6","chorioamnionitis","FIRS","lactates","labour","NOT_YET_RECRUITING","2025-09-30",{"date":38,"type":39},"2025-10-08","ACTUAL",{"date":41,"type":21},"2025-10-01",{"date":43,"type":21},"2027-04-30",{"name":45,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",""]