No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
120 (estimated)
Sponsor
Institute of Mother and Child, Warsaw, Poland · Other
Who this trial is looking for
This trial is looking for pregnant women who are at least 37 weeks along, either with a diagnosis of fetal growth restriction or with normal growth. Participants will provide cord blood samples after delivery for analysis of certain proteins and other health indicators.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 37 weeks pregnant.
I am having a single baby.
You may not be able to join if
I have conditions affecting blood flow in the placenta.
I smoke or use illicit substances.
I have been treated for depression with medication.
I have signs of infection during labor.
I have had prolonged labor lasting more than 15 hours.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 im…
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.
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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 smo…
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
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