COMPARISON OF DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION: THE IMPACT OF MIDDLE CEREBRAL ARTERY DOPPLER FINDINGS
| Registry | NCT07769957 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 120 (Estimated) |
| Sponsor | Istanbul Training and Research Hospital (Other gov) |
| Conditions | Fetal Growth Restriction (FGR) |
| Interventions | Diffusion-weighted fetal brain MRI (Diagnostic test) |
| Dates | start 2026-03-26, primary completion 2029-12-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-08-18, last updated 2026-08-20 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Fetal Growth Restriction (FGR) All trials of Diffusion-weighted fetal brain MRI
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| AGA - Normal MCA | Diagnostic Test: Diffusion-weighted fetal brain MRI | Appropriate for gestational age fetuses with normal MCA Doppler | |
| FGR - Normal MCA | Diagnostic Test: Diffusion-weighted fetal brain MRI | Growth restricted fetuses with normal MCA Doppler | |
| FGR - Abnormal MCA | Diagnostic Test: Diffusion-weighted fetal brain MRI | Growth restricted fetuses with abnormal MCA Doppler |
Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * Singleton pregnancy * Gestational age between 28 and 38 weeks * Maternal age between 18 and 45 years * For the FGR groups: estimated fetal weight (EFW) below the 10th percentile and/or abdominal circumference (AC) below the 10th percentile * For the control group: EFW and AC between the 10th and 90th percentiles, normal fetal Doppler findings, and no major structural anomaly on fetal anatomical examination * Written informed consent for participation in the study Exclusion Criteria: * Multiple pregnancy * Major fetal structural anomaly or diagnosed chromosomal abnormality * Contraindication to MRI, such as an MRI-incompatible implant * Maternal uncontrolled diabetes mellitus, significant thyroid disease, severe uncontrolled chronic hypertension, or other significant systemic chronic disease * Maternal age below 18 or above 45 years * Inability or unwillingness to provide informed consent or cooperate with study procedures
| Facility | City | Country | Status |
|---|---|---|---|
| Istanbul Training and Research Hospital Department of Obstetrics and Gynecology | Istanbul | Turkey (Türkiye) | Recruiting |