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

NCT ID: NCT05793970

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-25

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Intrauterine Infection Fetus Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Parma University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tullio Ghi

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tullio Ghi, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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University Hospital of Parma

Parma, , Italy

Site Status RECRUITING

Fondazione Universitaria Policlinico Gemelli

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Tullio Ghi, Professor

Role: CONTACT

Phone: +390521702434

Email: [email protected]

Facility Contacts

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Tullio Ghi, Professor

Role: primary

Elvira di Pasquo, MD

Role: backup

Antonio Lanzone, Professor

Role: primary

Alessandra Familiari, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 33164775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17762416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26360486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33765949 (View on PubMed)

Other Identifiers

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561/2021/OSS/AOUPR

Identifier Type: -

Identifier Source: org_study_id