ClinicalTrials.gg
RecruitingNCT07769957Updated Aug 20, 2026

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

An observational study in Fetal Growth Restriction (FGR), sponsored by Istanbul Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Istanbul Training and Research Hospital · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Fetal Growth Retardation with a site in Turkey — 3 open to participants now, 5 under way, none of them phase 3. Fetal Growth Retardation · Turkey.

Planned enrollment
5th of 13
120 · median 100
Started
2026
the only one that year
Observational
13 of 18
3 open now
Registered
18th of 18
by date
Lead sponsor
1 of 18
Istanbul Training and Research Hospital

Among the 18 studies in Fetal Growth Retardation with a site in Turkey, this one is the 5th largest by planned enrollment of the 13 observational ones, is the only one that started in 2026, is one of 13 observational ones, and was the 18th registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

Observationalthis study13 · 3 open
No phase5 · 0 open

By the year they started

First in 2015; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 149 across the 5 interventional studies, 100 across the 13 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies in Fetal Growth Retardation with a site in Turkey, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Fetal Growth Restriction (FGR)

Keywords

  • Fetal Growth Restriction
  • Diffusion-Weighted Imaging
  • Fetal MRI
  • MCA Doppler
  • Cerebral Redistribution
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation in the study

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancy
  • Major fetal structural anomaly or diagnosed chromosomal abnormality
  • 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 or cooperate with study procedures
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • AGA - Normal MCA

    Appropriate for gestational age fetuses with normal MCA Doppler

    Diagnostic Test: Diffusion-weighted fetal brain MRI

  • FGR - Normal MCA

    Growth restricted fetuses with normal MCA Doppler

    Diagnostic Test: Diffusion-weighted fetal brain MRI

  • FGR - Abnormal MCA

    Growth restricted fetuses with abnormal MCA Doppler

    Diagnostic Test: Diffusion-weighted fetal brain MRI

Interventions

  • Diagnostic testDiffusion-weighted fetal brain MRI

    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.

06

What researchers measure

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)

07

Study locations

1 of 1 sites recruiting
  • Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
    Istanbul, Turkey (Türkiye)
    Recruiting
    • Doruk C Katlan · Contactdcek2000@yahoo.com · +905353475411
    • Nebahat Uzunay · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2029, 45 months after the start.

Of 72 non-industry observational studies under Fetal Growth Retardation, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 170. This study's planned 45 months is below that.

Counting every sponsor, half of 73 studies reached it within 52 months; a quarter within 24 and three quarters within 170.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 18, 2026
StartActual
Mar 26, 2026
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2030
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07769957
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Doruk Cevdi Katlan (Maternal Fetal Medicine Specialist, Istanbul Training and Research Hospital) — Principal investigator
First posted
Aug 18, 2026
Start date
Mar 26, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 20, 2026

Study contacts

Doruk C Katlan
Contact
dcek2000@yahoo.com
+905353475411

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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