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

Recruiting

• Conditions: Intrauterine Infection; Fetus Disorder

• Registration Number: NCT05793970
• Lead Sponsor: Parma University Hospital

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.

Study Timeline

• Study Start: 2022-03-25
• Status Verified: 2023-03
• Study First Submitted: 2023-03-19
• Primary Completion: 2023-03-23
• Study First Submitted QC: 2023-03-30
• Last Update Submitted: 2023-03-30
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IL6 Levels	IL6 will be measured on the umbilical blood sampled within 5 minutes after birth	correlation between intrapartum CTG findings and IL-6 levels on the arterial cord

Trial Locations

Locations (2)

University Hospital of Parma; 🇮🇹 Parma, Italy

Fondazione Universitaria Policlinico Gemelli; 🇮🇹 Roma, Italy