💬In plain words
What the trial is, and whether it could suit you
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 art
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
HealthTeky