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Active Not Recruiting NCT07211503

IL-6 and Lactates in Cord Blood and Neonatal Outcomes

Conditions: Fetal Infection, Fetal Inflammatory Response Syndrome, Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 160
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Policlinico Gemelli Roma RM

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.

Eligibility Criteria

Inclusion Criteria: SOFI case group: * Women with gestational age \>37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor. * Single fetus in cephalic presentation * Age ≥18 years * Presence of CTG characteristics associated with fetal inflammation/infection (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 \37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor. * Single fetus in cephalic presentation. * Age ≥18 years. * Patients with a CTG tracing that does not show features associated with fetal inflammation/infection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm). * Patient signed informed consent form. Exclusion Criteria: * Failure to sign informed consent * Intrauterine fetal death * Congenital fetal and/or chromosomal abnormalities * Maternal cardiac abnormalities and/or cardiac therapy and/or therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin) * Twin or multiple pregnancy

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07211503). StuddyBuddy aggregates publicly available trial information.