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IL6 on Umbilical Cord (Evaluation of IL-6 Levels on Umbilical Cord)

Evaluation of IL-6 Levels on Umbilical Cord

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05793970
Acronym
INFIL-6
Enrollment
450
Registered
2023-03-31
Start date
2022-03-25
Completion date
2023-06-01
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetus Disorder, Intrauterine Infection

Brief summary

Fetal inflammatory response syndrome (FIRS) is a major cause of non-hypoxic fetal intrapartum injury. One of the most common determinants of FIRS during labor is the exposure to an ongoing intra-amniotic infectious agent as in the event of a chorioamnionitis. Interleuchine-6 (IL-6) is considered a reliable hallmark of FIRS. No specific fetal heart rate pattern for the diagnosis of FIRS have been described so far at intrapartum Cardiotocography (CTG). The aim the present study is to investigate the correlation between intrapartum CTG findings and IL-6 levels on the arterial cord.

Detailed description

The labor will be managed according to the local protocol and 5mL of blood will collected from the umbilical artery soon after birth to determine the IL-6 values. CardioTocography (CTG) traces will be retrospectively reviewed by two expert operators that will be blinded to the IL-6 results and will categorize them as inflammatory or not inflammatory. Inflammatory pattern will be defined in presence of 1) inappropriately high FHR for the given gestational age and/or 2) an increase \>10% compared with the FHR baseline values at admission without preceding deceleration with/without reduced variability or absent cycling. The association between CTG findings as the umbilical levels of IL6 will be analyzed.

Interventions

None listed

Sponsors

Parma University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* singleton pregnancies at term submitted to a continuous CTG tracing during labor

Exclusion criteria

elective Cesarean Delivery, maternal tachycardia or pyrexia \>38°C, drugs assumption \-

Design outcomes

Primary

MeasureTime frameDescription
IL6 LevelsIL6 will be measured on the umbilical blood sampled within 5 minutes after birthcorrelation between intrapartum CTG findings and IL-6 levels on the arterial cord

Countries

Italy

Contacts

Primary ContactTullio Ghi, Professor
tullio.ghi@unipr.it+390521702434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026