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临床试验/NCT04140669
NCT04140669终止不适用

Automated Myocardial Performance Index Before, During and After Fetal Surgeries Using Samsung HERA W10

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
7
试验地点
1
主要终点
Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

研究概览

简要总结

Researchers are using Myocardial performance index (MPI) to assess fetal cardiac function before, during, and after fetal surgery in order to gain more knowledge about fetal cardiac function in high risk pregnancies and the relationship to outcomes of fetal surgical interventions.

详细描述

This study will evaluate the cardiac function in fetuses with specific conditions before, during, and after fetal interventions using an automated myocardial performance index. It is hypothesized that automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

Ultrasound examination, including Doppler assessment, has served an axial rule in diagnosis and management of complex maternal-fetal conditions. Sonographic findings have been indicative of prognosis and have guided intervention at particular situations including intrauterine growth restriction and fetal alloimmunization. As researchers continue to investigate various sonographic parameters that would identify fetuses at increased risk of adverse outcomes, which would warrant intervention, fetal cardiac function has substantially attracted attention as a potential predictor of fetal status; subtle cardiac dysfunction may reflect functional adaptation to fetal insult.

Myocardial performance index (MPI) is a Doppler derived sonographic tool that is used to assess global fetal cardiac function. Higher MPI values have been proven to indicate ventricular dysfunction. Several studies have adopted the use of MPI as a part of fetal echocardiography, either to study normal values among fetal population or to assess fetal cardiac dysfunction in high risk pregnancy and in response to fetal intervention. Initial results have correlated MPI to adverse outcomes particularly in the presence of maternal and fetal disorders.

Fetal surgery is a unique stressful situation in which fetal cardiac function presents a critical aspect. In part, because underlying indications are commonly associated with clinically relevant myocardial dysfunction e.g. twin-to-twin transfusion syndrome (TTTS), congenital diaphragmatic hernia (CDH), neural tube defect (NTD) and lower urinary tract obstruction (LUTO). Moreover, surgery itself may be associated with significant fetal cardiac compromise. Therefore, perioperative (before, during and after the procedures) MPI may present a predictive parameter of fetal and neonatal outcomes in these high risk surgeries.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Automated MPI can used to diagnosis and predict fetal cardiac dysfunction in fetal surgeries.

时间窗: 48 hours post-operatively

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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