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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorIstanbul Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: AGA - Normal MCA1 intervention
Group B: FGR - Normal MCA1 intervention
Group C: FGR - Abnormal MCA1 intervention

Trial outcomes

Primary outcomes

1

Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values

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.

Time frame
At the time of fetal MRI examination (28-38 weeks of gestation)

Secondary outcomes

Other outcomes

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