DIFFUSION WEIGHTED MRI FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION
18. august 2026 opdateret af: Doruk Cevdi Katlan, Istanbul Training and Research Hospital
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
120
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Doruk C Katlan
- Telefonnummer: +905353475411
- E-mail: dcek2000@yahoo.com
Studiesteder
-
-
-
Istanbul, Tyrkiet (Türkiye)
- Rekruttering
- Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
-
Kontakt:
- Doruk C Katlan
- Telefonnummer: +905353475411
- E-mail: dcek2000@yahoo.com
-
Underforsker:
- Nebahat Uzunay
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Pregnant women with singleton pregnancies between 28 and 38 weeks of gestation who are followed at the Perinatology and Obstetrics and Gynecology outpatient clinics will be recruited.
The study population will include pregnancies complicated by fetal growth restriction (FGR) and healthy control pregnancies with fetuses appropriate for gestational age (AGA).
Participants will be classified into three groups according to fetal growth and middle cerebral artery (MCA) Doppler findings: FGR with normal MCA Doppler findings, FGR with MCA Doppler redistribution, and AGA healthy controls with normal Doppler findings.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. marts 2026
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2030
Datoer for studieregistrering
Først indsendt
13. august 2026
Først indsendt, der opfyldte QC-kriterier
13. august 2026
Først opslået (Faktiske)
18. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ISTANBUL TRH - 26.03.2026 - 69
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