An observational study in s100b, Hypoxia-Ischemia, Brain and Fetal Growth Restriction (FGR), sponsored by Institute of Mother and Child, Warsaw, Poland. Completed at 1 site in Poland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Institute of Mother and Child, Warsaw, Poland · Observational
S100B protein is a biomarker that increases following central nervous system (CNS) damage. Measuring this protein's levels may allow for the early identification of infants at high risk for developmental abnormalities, such as fetal growth restriction (FGR), even on the first day of life, in a non-invasive manner. Early detection could enable timely interventions and rehabilitation, potentially improving the child's prognosis and long-term outcomes. This study investigates two groups of full-term pregnancies: a study group with prenatally diagnosed late FGR, and a control group with normal fetal growth. Following delivery, cord blood samples from both groups will be analyzed for S100B protein concentrations, pH, base excess (BE), and lactate levels. Additionally, fetal blood flow parameters in the umbilical artery (UA), uterine arteries (UtA), ductus venosus (DV), and middle cerebral artery (MCA) will be monitored via ultrasound within 48 hours before delivery. This study aims to compare S100B protein concentrations in umbilical cord blood between the two groups and to assess correlations with fetal Doppler parameters, pH, BE, and lactate levels in cord blood gas analysis. Ultimately, we seek to determine the effectiveness of S100B protein concentration as a biomarker for diagnosing fetal CNS hypoxia- ischemia in FGR-affected children, compared to those with normal growth.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 95 are open to participants now.
This study's enrollment of 131 is above the median of 100 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Institute of Mother and Child, Warsaw, Poland is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with a full-term pregnancy.
Study Group - Inclusion Criteria:
Study Group - Exclusion Criteria:
Antenatal (at recruitment):
Intrapartum:
Control Group - Inclusion Criteria:
Control Group - Exclusion Criteria:
Antenatal (at recruitment):
Intrapartum:
Postnatal:
Women with a full-term pregnancy and a prenatal diagnosis of late-onset FGR.
Diagnostic Test: Prenatal ultrasound examination with blood flow analysis · Diagnostic Test: Umbilical cord blood gas analysis · Diagnostic Test: Umbilical cord blood S100B protein level · Diagnostic Test: Neonatal transfontanelle ultrasound assessment
Women with a full-term pregnancy and normal fetal development.
Diagnostic Test: Prenatal ultrasound examination with blood flow analysis · Diagnostic Test: Umbilical cord blood gas analysis · Diagnostic Test: Umbilical cord blood S100B protein level · Diagnostic Test: Neonatal transfontanelle ultrasound assessment
For all patients who provide informed consent to participate in the study, an ultrasound examination is performed within 48 hours prior to delivery. This assessment includes: 1. Measurement of fetal anthropometric parameters and estimation of fetal weight. 2. Evaluation of blood flow using the pulsatility index (PI) in the UA, UtA, DV, and MCA.
A 0.5 mL blood sample is collected from the clamped section of the umbilical cord and immediately sent to the laboratory for cord blood gas analysis, including the determination of pH, base excess (BE), and lactate levels.
A 1 mL sample of cord blood is collected in a labeled tube, which includes the mother's name, the child's gender, date of birth, and date of collection. The sample is then sent to the laboratory for centrifugation. The resulting serum samples are frozen, and once approximately 80 samples have been collected, they will be thawed and analyzed for S100B protein concentration. Any remaining material after laboratory processing will be properly disposed of.
A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Cord blood S100B protein concentration
The study's primary endpoint will be the concentration of S100B protein measured from a cord blood sample taken after birth in both the study and control groups.
Time frame: Within 3 months of enrollment
Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis
The potential correlation between cord blood S100B concentration and pH, BE, and lactate levels, as determined by cord blood gas analysis, in both the study and control groups.
Time frame: Within 3 months of enrollment
Association between cord blood S100B protein concentration and fetal blood flow parameters
The potential relationship between cord blood S100B protein concentration and blood flow parameters (PI) in the UA, UtA, DV, and MCA, as assessed by fetal ultrasound performed within 48 hours before delivery.
Time frame: Within 3 months of enrollment
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Institute of Mother and Child, Warsaw, Poland