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NCT Number: NCT07211503

IL-6 and Lactates in Cord Blood and Neonatal Outcomes

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.

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Key information

Conditions

Fetal Infection Chorioamnionitis Chorioamnionitis Affecting Fetus or Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Inflammatory Response Syndrome Fetal Membranes, Premature Rupture Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other

The study involves the collection of an additional aliquot of cord blood and an additional aliquot of maternal venous blood.

Primary outcomes

  1. fetal and maternal IL6 levels

    Time frame: 1 day

    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)

Secondary outcomes

  1. IL6 and neonatal outcome

    Time frame: 15 days

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

  2. IL6 and histopathology

    Time frame: 1 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elvira Di Pasquo

CONTACT

[email protected]

+39 0630155989

Laura Naccarato

CONTACT

[email protected]

+39 3480865246

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern

Acronym: ECCO-IL6

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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