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Fetal InfectionECCO-IL6NCT07211503

IL-6 and Lactates in Cord Blood and Neonatal Outcomes

An observational study of Fetal Infection and Fetal Inflammatory Response Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
blood sampling
How many people
160 participants
Where
1 siteItaly
Study dates
1 Oct 2025to 30 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Case group - SOFI: Women in labor at term with a CTG showing criteria "Suggestive for Fetal Inflammation." Control group - NEFI: Women in labor at term with a CTG showing no inflammation/infection characteristics.

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Policlinico Gemelli

    Roma, RM

Other trials in Italy

About this study

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

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.

Being tested
blood sampling
Keywords
il6, chorioamnionitis, FIRS, lactates, labour
Medical subject headings
fetal inflammatory response syndrome, Chorioamnionitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplingOther

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

Study groups in NCT07211503
Study groupRoleWhat they receive
SOFI groupWomen with a CTG trace suspicious for fetal infection/inflammation
Receives: Other: blood sampling
NEFI groupWomen with normal CTG tracings and no signs of inflammation.
Receives: Other: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fetal and maternal IL6 levels

    Comparison of fetal and maternal IL-6 levels between CTGs with "Suggestive for Fetal Inflammation" (SOFI) criteria and those with "Non Evidence of Fetal Inflammation" (NEFI)

    Measured: 1 day

Secondary outcomes (2)

  1. IL6 and neonatal outcome

    Comparison of fetal and maternal IL-6 levels between newborns with a composite adverse outcome

    Measured: 15 days

  2. IL6 and histopathology

    Comparison of fetal and maternal IL-6 levels in patients with and without signs of histological chorioamnionitis.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start1 Oct 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211503
Sponsor's protocol ID
7963
Acronym
ECCO-IL6
Status last verified
Sep 2025
First submitted
30 Sep 2025
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19529994

  • 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.

    PubMed 33765949

  • Varner MW, Marshall NE, Rouse DJ, Jablonski KA, Leveno KJ, Reddy UM, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Thorp JM, Malone FD, Carpenter M, O'Sullivan MJ, Peaceman AM, Hankins GD, Dudley DJ, Caritis SN; The Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units Network. The association of cord serum cytokines with neurodevelopmental outcomes. Am J Perinatol. 2015 Feb;30(2):115-22. doi: 10.1055/s-0034-1376185. Epub 2014 Jun 17.

    PubMed 24936937

  • Sorokin Y, Romero R, Mele L, Iams JD, Peaceman AM, Leveno KJ, Harper M, Caritis SN, Mercer BM, Thorp JM, O'Sullivan MJ, Ramin SM, Carpenter MW, Rouse DJ, Sibai B. Umbilical cord serum interleukin-6, C-reactive protein, and myeloperoxidase concentrations at birth and association with neonatal morbidities and long-term neurodevelopmental outcomes. Am J Perinatol. 2014 Sep;31(8):717-26. doi: 10.1055/s-0033-1359723. Epub 2013 Dec 11.

    PubMed 24338120

  • 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.

    PubMed 26360486

  • 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.

    PubMed 17762416

  • 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.

    PubMed 33164775

  • Chandraharan E, Pereira S, Ghi T, Gracia Perez-Bonfils A, Fieni S, Jia YJ, Griffiths K, Sukumaran S, Ingram C, Reeves K, Bolten M, Loser K, Carreras E, Suy A, Garcia-Ruiz I, Galli L, Zaima A. International expert consensus statement on physiological interpretation of cardiotocograph (CTG): First revision (2024). Eur J Obstet Gynecol Reprod Biol. 2024 Nov;302:346-355. doi: 10.1016/j.ejogrb.2024.09.034. Epub 2024 Oct 2.

    PubMed 39378709

Questions about this trial

What is this clinical trial studying?

An observational study of Fetal Infection and Fetal Inflammatory Response Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fetal and maternal IL6 levels (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211503, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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IL-6 and Lactates in Cord Blood and Neonatal Outcomes | AzTrials