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DIFFUSION WEIGHTED MRI FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study title expanded, about 1 wordv2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective observational study aims to compare fetal brain diffusion-weighted magnetic resonance imaging (DWI) findings in fetuses with and without fetal growth restriction (FGR) and to evaluate the association between middle cerebral artery (MCA) Doppler findings and regional apparent diffusion coefficient (ADC) values. Participants will be classified into three groups: fetuses with FGR and normal MCA Doppler findings, fetuses with FGR and MCA Doppler redistribution, and appropriately grown for gestational age (AGA) healthy control fetuses with normal Doppler findings. Fetal DWI will be performed using a 1.5-Tesla MRI scanner, and ADC values will be measured in predefined brain regions, including the frontal, occipital, and temporal white matter, thalamus, pons, cerebellar hemispheres, and centrum semiovale. The primary objective is to compare regional ADC values between fetuses with FGR and healthy controls. The secondary objective is to determine whether ADC values differ between FGR fetuses with normal MCA Doppler findings and those with MCA Doppler redistribution. The study also aims to evaluate the relationship between ADC values, gestational age, fetal biometric measurements, and Doppler parameters.
Trial Details
NCT Number NCT07769957
Lead Sponsor Istanbul Training and Research Hospital
Conditions
(from sponsor)
Fetal Growth Restriction (FGR)
Related terms Fetal Growth Retardation
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov