IL-6 and Lactates in Cord Blood and Neonatal Outcomes

Официальное название

Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern

Обзор

The goal of this observational study or clinical trial is to evaluate interleukin-6 (IL-6) and lactate levels in maternal and cord blood to identify early signs of fetal inflammation or infection. Two groups of women with full-term pregnancies will be compared: • Case group (SOFI): women with a cardiotocograph (CTG) pattern suspicious for fetal infection/inflammation • Control group (NEFI): women with a normal cardiotocograph (CTG) pattern without signs of inflammation. The primary outcome is to evaluate whether IL-6 levels detected in the umbilical artery, alone or in combination with maternal IL-6 values, are associated with a cardiotocograph (CTG) pattern suggestive of fetal inflammation and/or a clinical picture suggestive of chorioamnionitis. Identifying a possible correlation between IL-6/lactate levels and fetal inflammatory status could facilitate more timely treatment of at-risk infants in the future, contributing to the reduction of adverse outcomes both in the neonatal period and in the long-term. Secondary outcome are: -Comparison of fetal and maternal IL-6 levels between infants with a composite adverse outcome; - Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.

Вмешательства

• Другое blood sampling
  The study involves the collection of an additional aliquot of cord blood and an additional aliquot of maternal venous blood.

Первичные конечные точки

• fetal and maternal IL6 levels [Срок оценки: 1 day]

Вторичные конечные точки (2)

• IL6 and neonatal outcome [Срок оценки: 15 days]
• IL6 and histopathology [Срок оценки: 1 month]

Критерии участия

Критерии включения

SOFI case group:

• Women with gestational age >37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.
• Single fetus in cephalic presentation
• Age ≥18 years
• Presence of CTG characteristics associated with fetal inflammation/infection (fetal heart rate (fetal heart rate (FHR) >150 bpm with gestational age >40 weeks or a 10% increase in FHR, absence of cycling, fetal tachycardia >=160 bpm, variability <5 bpm)
• Signed informed consent form by the patient.

NEFI control group:

• Women with gestation >37 weeks who access the delivery room of the Obstetrics and Obstetric Pathology Unit for labor.
• Single fetus in cephalic presentation.
• Age ≥18 years.
• Patients with a CTG tracing that does not show features associated with fetal inflammation/infection (fetal heart rate (FHR) between 110-150 bpm, normal cycling, and normal variability between 5 and 25 bpm).
• Patient signed informed consent form.

Критерии исключения

• Failure to sign informed consent
• Intrauterine fetal death
• Congenital fetal and/or chromosomal abnormalities
• Maternal cardiac abnormalities and/or cardiac therapy and/or therapy with a direct effect on maternal heart rate (e.g., labetalol, digoxin)
• Twin or multiple pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• Policlinico Gemelli — Roma

Публикации

• Chan CJ, Summers KL, Chan NG, Hardy DB, Richardson BS. Cytokines in umbilical cord blood and the impact of labor events in low-risk term pregnancies. Early Hum Dev. 2013 Dec;89(12):1005-10. doi: 10.1016/j.earlhumdev.2013.08.017. Epub 2013 Sep 14. PMID 24045131
• Su H, Chang SS, Han CM, Wu KY, Li MC, Huang CY, Lee CL, Wu JY, Lee CC. Inflammatory markers in cord blood or maternal serum for early detection of neonatal sepsis-a systemic review and meta-analysis. J Perinatol. 2014 Apr;34(4):268-74. doi: 10.1038/jp.2013.186. Epub 2014 Jan 23. PMID 24457256
• Kim CJ, Yoon BH, Romero R, Moon JB, Kim M, Park SS, Chi JG. Umbilical arteritis and phlebitis mark different stages of the fetal inflammatory response. Am J Obstet Gynecol. 2001 Aug;185(2):496-500. doi: 10.1067/mob.2001.116689. PMID 11518916
• Tsukimori K, Komatsu H, Yoshimura T, Hikino S, Hara T, Wake N, Nakano H. Increased inflammatory markers are associated with early periventricular leukomalacia. Dev Med Child Neurol. 2007 Aug;49(8):587-90. doi: 10.1111/j.1469-8749.2007.00587.x. PMID 17635203
• Daskalakis G, Papapanagiotou A, Siristatidis C, Drakakis P, Mole I, Barbouni A, Papavassiliou AG, Pergialiotis V. The influence of delayed cord clamping and cord milking on inflammatory cytokines in umbilical vein and neonatal circulation. Acta Obstet Gynecol Scand. 2018 May;97(5):624-628. doi: 10.1111/aogs.13294. Epub 2018 Feb 8. PMID 29338067
• Aydin I, Aydin FN, Agilli M. The evaluation of inflammatory markers in umbilical cord blood. Fetal Pediatr Pathol. 2014 Jun;33(3):196-7. doi: 10.3109/15513815.2014.898722. Epub 2014 Mar 27. PMID 24673641
• Oh JW, Park CW, Moon KC, Park JS, Jun JK. The relationship among the progression of inflammation in umbilical cord, fetal inflammatory response, early-onset neonatal sepsis, and chorioamnionitis. PLoS One. 2019 Nov 19;14(11):e0225328. doi: 10.1371/journal.pone.0225328. eCollection 2019. PMID 31743377
• Mestan K, Yu Y, Thorsen P, Skogstrand K, Matoba N, Liu X, Kumar R, Hougaard DM, Gupta M, Pearson C, Ortiz K, Bauchner H, Wang X. Cord blood biomarkers of the fetal inflammatory response. J Matern Fetal Neonatal Med. 2009 May;22(5):379-87. doi: 10.1080/14767050802609759. PMID 19529994

Идентификаторы

NCT: NCT07211503 · 7963

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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