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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.
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.
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:elective Cesarean Delivery, maternal tachycardia or pyrexia >38°C, drugs assumption
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Pregnant women
singleton pregnancies at term submitted to a continuous CTG tracing during labor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tullio Ghi, Professor | Contact | +390521702434 | tullio.ghi@unipr.it |
| Name | Affiliation | Role |
|---|---|---|
| Tullio Ghi, Professor | University of Parma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Parma | Recruiting | Parma | 43123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33164775 | Background | 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. | |
| 17762416 |
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| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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5mL of umbilical cord blood will be sampled
| Fondazione Universitaria Policlinico Gemelli | Recruiting | Roma | 00186 | Italy |
|
| 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. |
| 26360486 | 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. |
| 33765949 | 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. |