IL-6 and Lactates in Cord Blood and Neonatal Outcomes

N/ANot Yet RecruitingNCT07211503

Fondazione Policlinico Universitario Agostino Gemelli IRCCS160 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Fetal Infection Fetal Inflammatory Response Syndrome Chorioamnionitis Chorioamnionitis Affecting Fetus or Newborn

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \<5 bpm) * Signed informed consent form by the patient. NEFI control group: * Women with gestation \>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

Outcomes

Primary Outcomes

fetal and maternal IL6 levels

Comparison of fetal and maternal IL-6 levels between CTGs with "Suggestive for Fetal Inflammation" (SOFI) criteria and those with "Non Evidence of Fetal Inflammation" (NEFI)

Time frame: 1 day

Secondary Outcomes

IL6 and neonatal outcome

Comparison of fetal and maternal IL-6 levels between newborns with a composite adverse outcome

Time frame: 15 days

IL6 and histopathology

Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.

Time frame: 1 month