Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Launched by INSTITUTE OF MOTHER AND CHILD, WARSAW, POLAND · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the levels of a protein called S100B in the cord blood of newborns, specifically those who have been diagnosed with fetal growth restriction (FGR) compared to those with normal growth. S100B is a marker that can indicate damage to the brain, and measuring its levels soon after birth could help identify babies at risk for developmental issues early on. The goal is to see if testing for S100B can help doctors provide timely care and improve outcomes for these infants.

To participate in this study, women must be at least 37 weeks pregnant with a single baby. Those with FGR will be included, while those with certain health conditions, such as diabetes or infections, will be excluded. Participants will have their baby's cord blood tested after birth and will undergo ultrasound checks of blood flow before delivery. This research aims to better understand how S100B levels relate to the health of the baby and potentially enhance care for infants facing challenges due to FGR.

Gender

FEMALE

Eligibility 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 - Exclusion Criteria:
• 1. Antenatal (at recruitment):
• • Maternal conditions that may affect placental blood flow, such as smoking, use of illicit stimulant substances, pregestational diabetes, or chronic hypertension.
• • Maternal depression requiring pharmacological treatment (e.g., SSRIs).
• • Risk factors for intrauterine HI, including abnormal fetal blood flow parameters on ultrasound, abnormal CTG recordings, or the need for intrauterine transfusion.
• 2. Intrapartum:
• • Indicators of possible intrauterine infection, such as amniotic fluid leakage for more than 15 hours, spontaneous preterm delivery, diagnosed intrauterine infection, or maternal symptoms of infection.
• • Risk factors for perinatal HI.
• • Prolonged labor lasting more than 15 hours (counted from the onset of regular uterine contractions).
• • Birth weight below the 10th percentile or above the 90th percentile.
• • Apgar score less than 8 at the 1st, 3rd, 5th, or 10th minute of life.
• • Abnormal umbilical cord blood gas analysis results, defined as pH \< 7.15 or BE \< -9.3 mmol/l.
• 3. Postnatal:
• • Neonatal anemia requiring a top-up transfusion within the first 24 hours of life