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

Evaluation of IL-6 Levels on Umbilical Cord

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.

Study Overview

• Status: Recruiting
• Conditions: Intrauterine Infection; Fetus Disorder

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 Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Tullio Ghi, Professor; Phone Number: +390521702434; Email: tullio.ghi@unipr.it

Study Locations

• Italy
  • Parma, Italy, 43123
    • Recruiting
    • University Hospital of Parma
    • Contact: Tullio Ghi, Professor
    • Contact: Elvira di Pasquo, MD
  • Roma, Italy, 00186
    • Recruiting
    • Fondazione Universitaria Policlinico Gemelli
    • Contact: Antonio Lanzone, Professor
    • Contact: Alessandra Familiari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Parma University Hospital
• Investigators: Principal Investigator: Tullio Ghi, Professor, University of Parma

Publications and helpful links

General Publications

• Jung E, Romero R, Yeo L, Diaz-Primera R, Marin-Concha J, Para R, Lopez AM, Pacora P, Gomez-Lopez N, Yoon BH, Kim CJ, Berry SM, Hsu CD. The fetal inflammatory response syndrome: the origins of a concept, pathophysiology, diagnosis, and obstetrical implications. Semin Fetal Neonatal Med. 2020 Aug;25(4):101146. doi: 10.1016/j.siny.2020.101146. Epub 2020 Oct 23.
• Gotsch F, Romero R, Kusanovic JP, Mazaki-Tovi S, Pineles BL, Erez O, Espinoza J, Hassan SS. The fetal inflammatory response syndrome. Clin Obstet Gynecol. 2007 Sep;50(3):652-83. doi: 10.1097/GRF.0b013e31811ebef6.
• Romero R, Chaemsaithong P, Docheva N, Korzeniewski SJ, Tarca AL, Bhatti G, Xu Z, Kusanovic JP, Chaiyasit N, Dong Z, Yoon BH, Hassan SS, Chaiworapongsa T, Yeo L, Kim YM. Clinical chorioamnionitis at term V: umbilical cord plasma cytokine profile in the context of a systemic maternal inflammatory response. J Perinat Med. 2016 Jan;44(1):53-76. doi: 10.1515/jpm-2015-0121.
• Ren J, Qiang Z, Li YY, Zhang JN. Biomarkers for a histological chorioamnionitis diagnosis in pregnant women with or without group B streptococcus infection: a case-control study. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):250. doi: 10.1186/s12884-021-03731-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Anticipated): March 23, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Fetal Diseases
• Other Study ID Numbers: 561/2021/OSS/AOUPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No