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临床试验/NCT06215690
NCT06215690进行中(未招募)不适用

Evaluation of Anterior Middle Brain Structures With Cerebrovascular Flow in Fetuses With Fetal Growth Restriction

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation

研究概览

简要总结

The study will be conducted to examine the effects of abnormal growth pattern and cerebrovascular blood flow measurements on fetal frontal lobe development with the advancing ultrasound technology. Antenatal assessment of frontal lobe development will enable clinicians to predict neurodevelopmental problems that may develop postnatally. In addition, this study will examine the effects of FGR on frontal lobe development.

详细描述

Fetal growth restriction (FGR) affects up to 10% of all pregnancies. The International Society of Ultrasound in Obstetrics & Gynecology (ISUOG) adopts the Delphi consensus criteria for the definition of FGR. These criteria include estimated fetal weight (EFW) or abdominal circumference (AC) < 3rd percentile or EFW or AC < 10th percentile with abnormal Doppler findings or decreased growth percentiles. FGR is a cause of perinatal morbidity and mortality. These perinatal outcomes include cardiovascular, endocrine and neurodevelopmental disorders. Fetal growth restriction, which is associated with lower neurobehavioral test scores, is associated with significant postnatal costs for both the health care system and families. Previous literature has shown that three-dimensional ultrasonography of intracranial structures reveals significant differences between fetuses with FGR and gestational age-appropriate (AGA) fetuses. However, the limited use of three-dimensional ultrasonography has hindered clinical applications. The frontal Anterior-Posterior Diameter (FAPD)/Occipital-Frontal Diameter (OFD) ratio has recently been used to assess frontal lobe development in fetuses with congenital heart disease. The FAPD is obtained by measuring from the inner line of the frontal bone along the fetal brain midline to the posterior edge of the CSP. This measurement refers to the frontal lobe of the fetal cerebrum. This study was designed to investigate the FAPD/ OFD ratio and frontal lobe development in fetuses with FGR and to evaluate cerebrovascular flow and anterior midbrain structures in FGR fetuses.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
32 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy hearts between the ages of 18-40
  • Singleton pregnancies
  • 32 to 37 weeks gestational week range

排除标准

  • Multiple pregnancies
  • Fetuses with fetal karyotype abnormalities
  • Pregnant women with co-morbidity
  • Fetuses with fetal intracranial hemorrhage
  • Fetuses with cranial anomalies
  • Maternal obesity preventing measurement

结局指标

主要结局

Ultrasonographic measurements and comparison of fetuses with and without fetal growth retardation

时间窗: Prenatal (32-37 gestational weeks)

Demographic data, ultrasonographically obtained biometric measurements, and Doppler flow data will be compared in both groups. * Frontal Anterior Posterior Length, Occipital to Frontal Diameter ratio mm/mm (FAPD mm/OFD mm) * Cerebellar length, head circumference length ratio mm/mm (CD mm / HC mm) The main biometric measurement of the study will be comparison. The percentile values of the Anterior Cerebral Artery Doppler Pulsatility Index (cm/s) (ACA PI cm/s ) and Middle Cerebral Artery Doppler Pulsatility Index cm/s (MCA PI cm/s) will be calculated for the week of ultrasonographic measurement, and the ratio of ACA PI and MCA PI will be compared in fetuses with and without fetal growth retardation.

次要结局

  • Evaluation of neonatal findings of the patients included in the study(through study completion, an average of 4 months)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Can Ozan Ulusoy

Principal Investigator

Ankara Etlik City Hospital

研究点 (1)

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