NCT05793970|Unknown
IL6 on Umbilical Cord (Evaluation of IL-6 Levels on Umbilical Cord)
INFIL-6
Evaluation of IL-6 Levels on Umbilical Cord
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INFIL-6
Evaluation of IL-6 Levels on Umbilical Cord
Sponsor study identifier
observational
450
1 country
2
Study Start
March 25, 2022
Actual (reported)Primary Completion
March 23, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2022
Actual (reported)March 19, 2023
Actual (reported)March 23, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2023
Actual (reported)June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
singleton pregnancies at term submitted to a continuous CTG tracing during labor
University Hospital of Parma
Parma, 43123, Italy
Fondazione Universitaria Policlinico Gemelli
Roma, 00186, Italy
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.
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.
5mL of umbilical cord blood will be sampled
Tullio Ghi, Professor
University of Parma
First Submitted
March 19, 2023
First Posted
March 31, 2023
Study Start
March 25, 2022
Actual (reported)Primary Completion
March 23, 2023
Estimated (date passed)Contact the study team to confirm eligibility.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2023
Record last verified: 2023-03
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