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NCT Number: NCT07769957

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

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.

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Key information

Conditions

Fetal Growth Restriction (FGR) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul Training and Research Hospital Department of Obstetrics and Gynecology

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Doruk C Katlan

CONTACT

[email protected]

+905353475411

Nebahat Uzunay

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion-weighted fetal brain MRI

Diagnostic Test

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.

Primary outcomes

Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doruk C Katlan

CONTACT

[email protected]

+905353475411

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

COMPARISON OF DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION: THE IMPACT OF MIDDLE CEREBRAL ARTERY DOPPLER FINDINGS

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Aug 18, 2026
Registry last updated: Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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