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Simple cord blood test may detect fetal infection early
NCT ID NCT07211503
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study looks at whether measuring IL-6 and lactate in cord blood can detect early signs of infection or inflammation in full-term newborns. Researchers will compare 160 women whose fetal heart rate patterns suggest possible inflammation with those whose patterns are normal. If a link is found, it could help doctors treat at-risk babies sooner and reduce long-term health problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors identify and treat newborns at risk of infection or inflammation more quickly.
- What could go wrong
- This is an early observational study with only 160 participants, so results may not apply to all pregnancies. It measures markers, not outcomes, so it may not change care directly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Policlinico Gemelli
Roma, RM, Italy
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Other studies related to the condition(s) this trial covers.