IL-6 and Lactates in Cord Blood and Neonatal Outcomes (ECCO-IL6)

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Not yet enrolling

Conditions

Chorioamnionitis

Fetal Infection

Fetal Inflammatory Response Syndrome

Chorioamnionitis Affecting Fetus or Newborn

Treatments

Other: blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT07211503

7963

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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