Trials / Not Yet Recruiting
Not Yet RecruitingNCT07211503
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Evaluating Correlation Ccrd Blood IL 6 and Neonatal Outcome and CTG Inflammatory Pattern
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 160 (estimated)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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. 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.
Conditions
- Fetal Infection
- Fetal Inflammatory Response Syndrome
- Chorioamnionitis
- Chorioamnionitis Affecting Fetus or Newborn
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | blood sampling | The study involves the collection of an additional aliquot of cord blood and an additional aliquot of maternal venous blood. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-03-31
- Completion
- 2027-04-30
- First posted
- 2025-10-08
- Last updated
- 2025-10-08
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT07211503. Inclusion in this directory is not an endorsement.