Status:
NOT_YET_RECRUITING
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Fetal Infection
Fetal Inflammatory Response Syndrome
Eligibility:
FEMALE
18+ years
Brief 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. Tw...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07211503
Start Date
October 1 2025
End Date
April 30 2027
Last Update
October 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Policlinico Gemelli
Roma, RM, Italy