Fetal brain diffusion MRI in growth-restricted pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study compares regional brain diffusion measurements from diffusion-weighted MRI in fetuses with fetal growth restriction (FGR) to those in appropriately grown fetuses. Fetuses are grouped by FGR with normal MCA Doppler, FGR with MCA Doppler redistribution, and healthy controls with normal Doppler. MRI is performed at 1.5 Tesla, and fractional regions such as frontal, occipital, temporal white matter, thalamus, pons, cerebellum, and centrum semiovale are analyzed for apparent diffusion coefficient values. The primary aim is to identify differences in regional ADC values between FGR and controls; a secondary aim considers the relationship between MCA Doppler findings and ADC patterns. This is an observational, non-interventional study designed to explore potential brain diffusion changes associated with FGR.

Why it matters

Who can join: the full rules

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

Where it's running

• Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Doruk C Katlan
• Email: dcek2000@yahoo.com
• Phone: +905353475411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.