IL-6 and Lactates in Cord Blood and Neonatal Outcomes

Not yet recruiting

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

• Registration Number: NCT07211503
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study Start: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2027-03-31
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fetal and maternal IL6 levels	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 Outcome Measures

Name	Time	Method
IL6 and neonatal outcome	15 days	Comparison of fetal and maternal IL-6 levels between newborns with a composite adverse outcome
IL6 and histopathology	1 month	Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.

Trial Locations

Locations (1)

Policlinico Gemelli; 🇮🇹 Roma, RM, Italy