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

Fetus Disorder Clinical Trial

— INFIL-6  

Official title:

Evaluation of IL-6 Levels on Umbilical Cord

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793970
• Other study ID #: 561/2021/OSS/AOUPR
• Status: Recruiting
• Start date: March 25, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: Parma University Hospital
• Contact: Tullio Ghi, Professor
• Phone: +390521702434
• Email: tullio.ghi[@]unipr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 1, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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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Related Conditions & MeSH terms

• Fetus Disorder

Locations

Country	Name	City	State
Italy	University Hospital of Parma	Parma
Italy	Fondazione Universitaria Policlinico Gemelli	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Parma University Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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