An observational study in Fetal Infection, Fetal Inflammatory Response Syndrome and Chorioamnionitis, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
39 studies on the registry are indexed under Chorioamnionitis; 9 are open to participants now.
This study's planned enrollment of 160 is above the median of 125 across 14 observational studies indexed under Chorioamnionitis.
Browse Chorioamnionitis studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Case group - SOFI: Women in labor at term with a CTG showing criteria "Suggestive for Fetal Inflammation." Control group - NEFI: Women in labor at term with a CTG showing no inflammation/infection characteristics.
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SOFI case group:
NEFI control group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with a CTG trace suspicious for fetal infection/inflammation
Other: blood sampling
Women with normal CTG tracings and no signs of inflammation.
Other: blood sampling
The study involves the collection of an additional aliquot of cord blood and an additional aliquot of maternal venous blood.
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
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
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →