Status:
RECRUITING
Cord Blood S100B Protein Levels in Neonates Following Intrauterine Transfusions for HDFN-Associated Fetal Anemia
Lead Sponsor:
Institute of Mother and Child, Warsaw, Poland
Conditions:
s100b
Hypoxia-Ischemia, Brain
Eligibility:
FEMALE
18+ years
Brief Summary
levated levels of S100B protein are a well-established marker of central nervous system (CNS) damage. Fetal anemia resulting from hemolytic disease of the fetus and newborn (HDFN) often necessitates i...
Eligibility Criteria
Inclusion
- Study Group -
- Singleton pregnancy.
- Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
- Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
- Fetal anemia requiring IUT, indicated by a MCA-PSV MoM value exceeding 1.5.
- Study Group -
Exclusion
- 1\. Maternal chronic use of selective serotonin reuptake inhibitors (SSRIs).
- Control Group - Inclusion Criteria:
- Singleton pregnancy.
- Diagnosis of HDFN confirmed by the detection of alloantibodies through maternal blood screening.
- Availability of complete medical records, including routine ultrasound assessments of fetal MCA blood flow.
- No indications for IUT, as determined by MCA-PSV MoM values \<1.5 in routine assessments of fetal cerebral arterial flow.
- Control Group -
Key Trial Info
Start Date :
July 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06984445
Start Date
July 17 2024
End Date
April 30 2026
Last Update
May 22 2025
Active Locations (1)
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1
Institute of Mother and Child
Warsaw, Poland, 01-211