此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2026年8月18日 更新者：Doruk Cevdi Katlan、Istanbul Training and Research Hospital

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 土耳其（türkiye）
      • Istanbul、土耳其（türkiye）
        • 招聘中
        • Istanbul Training and Research Hospital Department of Obstetrics and Gynecology
        • 接触：
        • 副研究员：
          • Nebahat Uzunay

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
AGA - Normal MCA
Appropriate for gestational age fetuses with normal MCA Doppler
诊断测试：Diffusion-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.
FGR - Normal MCA
Growth restricted fetuses with normal MCA Doppler
诊断测试：Diffusion-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.
FGR - Abnormal MCA
Growth restricted fetuses with abnormal MCA Doppler
诊断测试：Diffusion-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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Regional Fetal Brain Apparent Diffusion Coefficient (ADC) Values
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Istanbul Training and Research Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月26日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年8月13日

首先提交符合 QC 标准的

2026年8月13日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ISTANBUL TRH - 26.03.2026 - 69

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅