Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793970
Status:
RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-19
Brief Title:
IL6 on Umbilical Cord Evaluation of IL-6 Levels on Umbilical Cord
Sponsor:
Parma University Hospital
Organization:
Parma University Hospital
Study Overview
Official Title:
Evaluation of IL-6 Levels on Umbilical Cord
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFIL-6
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
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 andor 2 an increase 10 compared with the FHR baseline values at admission without preceding deceleration withwithout reduced variability or absent cycling
The association between CTG findings as the umbilical levels of IL6 will be analyzed
Inflammatory pattern will be defined in presence of 1 inappropriately high FHR for the given gestational age andor 2 an increase 10 compared with the FHR baseline values at admission without preceding deceleration withwithout reduced variability or absent cycling
The association between CTG findings as the umbilical levels of IL6 will be analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None