- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07769957
DIFFUSION WEIGHTED MRI FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION
COMPARISON OF DIFFUSION WEIGHTED MAGNETIC RESONANCE IMAGING FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION: THE IMPACT OF MIDDLE CEREBRAL ARTERY DOPPLER FINDINGS
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Doruk C Katlan
- Telefonnummer: +905353475411
- E-post: dcek2000@yahoo.com
Studieorter
-
-
-
Istanbul, Turkiet (Türkiye)
- Rekrytering
- Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
-
Kontakt:
- Doruk C Katlan
- Telefonnummer: +905353475411
- E-post: dcek2000@yahoo.com
-
Underutredare:
- Nebahat Uzunay
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
AGA - Normal MCA
Appropriate for gestational age fetuses with normal MCA Doppler
|
Fetal diffusion-weighted magnetic resonance imaging (DWI) will be performed using a 1.5-Tesla MRI scanner.
Diffusion-weighted images will be acquired with b-values of 0 and 1000 s/mm², and apparent diffusion coefficient (ADC) maps will be generated.
Region-of-interest (ROI)-based ADC measurements will be obtained from predefined fetal brain regions.
|
|
FGR - Normal MCA
Growth restricted fetuses with normal MCA Doppler
|
Fetal diffusion-weighted magnetic resonance imaging (DWI) will be performed using a 1.5-Tesla MRI scanner.
Diffusion-weighted images will be acquired with b-values of 0 and 1000 s/mm², and apparent diffusion coefficient (ADC) maps will be generated.
Region-of-interest (ROI)-based ADC measurements will be obtained from predefined fetal brain regions.
|
|
FGR - Abnormal MCA
Growth restricted fetuses with abnormal MCA Doppler
|
Fetal diffusion-weighted magnetic resonance imaging (DWI) will be performed using a 1.5-Tesla MRI scanner.
Diffusion-weighted images will be acquired with b-values of 0 and 1000 s/mm², and apparent diffusion coefficient (ADC) maps will be generated.
Region-of-interest (ROI)-based ADC measurements will be obtained from predefined fetal brain regions.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values
Tidsram: At the time of fetal MRI examination (28-38 weeks of gestation)
|
Apparent diffusion coefficient (ADC) values will be measured using region-of-interest (ROI) analysis on fetal diffusion-weighted MRI in the frontal, occipital, and temporal white matter, thalamus, pons, cerebellar hemispheres, and centrum semiovale.
Mean ADC values will be compared among fetuses with FGR and normal MCA Doppler, fetuses with FGR and MCA Doppler redistribution, and AGA healthy controls.
ADC values will be expressed in mm²/s.
|
At the time of fetal MRI examination (28-38 weeks of gestation)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ISTANBUL TRH - 26.03.2026 - 69
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .