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