Fetal Growth Restriction (FGR), Hypoxia-Ischemia, Brain, s100b
Conditions
Keywords
S100B protein, fetal growth restriction (FGR), newborn, central nervous system (CNS) damage, CNS hypoxia-ischemia (HI)
Brief summary
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.
Interventions
DIAGNOSTIC_TESTPrenatal ultrasound examination with blood flow analysis
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.
DIAGNOSTIC_TESTUmbilical cord blood gas analysis
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.
DIAGNOSTIC_TESTUmbilical cord blood S100B protein level
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.
DIAGNOSTIC_TESTNeonatal transfontanelle ultrasound assessment
A transfontanelle ultrasound examination is performed to assess for any abnormalities in the newborn.
Sponsors
Institute of Mother and Child, Warsaw, Poland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study Group - Inclusion Criteria: 1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton. 2. Pregnancy complicated by FGR. Study Group -
Exclusion criteria
1. Antenatal (at recruitment): * Maternal conditions that may affect the blood flow in placental vessels, including smoking, use of illicit stimulant substances, or pregestational diabetes. * Maternal depression requiring pharmacological treatment (e.g., SSRIs). 2. Intrapartum: * Factors indicating a possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm labor, diagnosed intrauterine infection, or symptoms of infection in the mother. * Prolonged labor lasting more than 15 hours. Control Group - Inclusion Criteria: 1. Women with a full-term pregnancy (≥37 weeks of gestation), singleton. 2. Pregnancy not complicated by FGR. Control Group -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cord blood S100B protein concentration | Within 3 months of enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of cord blood S100B concentration with pH, BE, and lactate levels in cord blood gas analysis | Within 3 months of enrollment | 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. |
| Association between cord blood S100B protein concentration and fetal blood flow parameters | Within 3 months of enrollment | 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. |
Countries
Poland
Contacts
Primary ContactAgnieszka A. Drozdowska-Szymczak, MD, PhD
Backup ContactSabina A. Łukawska, MD
Outcome results
None listed