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

NCT05793970 | Unknown

• 1 other identifier: 561/2021/OSS/AOUPR
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

Intrauterine Infection; Fetus Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Parma University Hospital: lead

Study Sites (2)

University Hospital of Parma

Parma, 43123, Italy

RECRUITING

Fondazione Universitaria Policlinico Gemelli

Roma, 00186, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 33164775 BACKGROUND

• 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.

  PMID: 17762416 BACKGROUND

• 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.

  PMID: 26360486 BACKGROUND

• 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.

  PMID: 33765949 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

5mL of umbilical cord blood will be sampled

MeSH Terms

Conditions

Fetal Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tullio Ghi, Professor

  University of Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tullio Ghi, Professor

CONTACT

+390521702434; tullio.ghi@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: March 25, 2022
• Primary Completion: March 23, 2023
• Study Completion: June 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

IT (2)