Clinical Trial

IL-6 and Lactates in Cord Blood and Neonatal Outcomes

Study acronym: ECCO-IL6
Not Yet Recruiting
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Summary
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. Two groups of women with full-term pregnancies will be compared: • Case group (SOFI): women with a cardiotocograph (CTG) pattern suspicious for fetal infection/inflammation • 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/or a clinical picture suggestive of chorioamnionitis. Identifying a possible correlation between IL-6/lactate 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. Secondary 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.
Trial Details
NCT Number NCT07211503
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Fetal Infection, Fetal Inflammatory Response Syndrome, Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
Enrollment 160 participants
Start Date 2025-10-01
Primary Completion 2027-03-31 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-08