DIFFUSION WEIGHTED MRI FINDINGS IN FETUSES WITH AND WITHOUT FETAL GROWTH RESTRICTION
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Doruk C Katlan
- 電話番号:+905353475411
- メール:dcek2000@yahoo.com
研究場所
-
-
-
Istanbul、トルコ(Türkiye)
- 募集
- Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
-
コンタクト:
- Doruk C Katlan
- 電話番号:+905353475411
- メール:dcek2000@yahoo.com
-
副調査官:
- Nebahat Uzunay
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values
時間枠: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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ISTANBUL TRH - 26.03.2026 - 69
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。