Evaluation of Fetal Cardiac Function With aCMQ-STRAIN: Normality Curve and Comparison to Fetus With Cardiac Disfunction Risk Factors
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- Changes in the shortening of cardiac fibers during cardiac cycle
研究概览
简要总结
To assess whether the aCQM-Strain ultrasound method allows a good analysis of fetal cardiac function. Establish normality parameters and compare it with fetuses with risk factors of cardiac dysfunction.
详细描述
National unicentric observational study of follow-up study of a cohort. It has been decided to conduct a study of consecutive cases, including all patients who meet the inclusion criteria during the time of the study.
Until now, there has not been an easy and convenient method to determine fetal cardiac function. Recently a new Software (Automated Cardiac Motion Quantification aCMQ) has been developed, and it seems that allows an easier analysis of this one.
This study aims to analyze fetal heart function with the Strain method in healthy patients and then compare it with fetuses with risk factors for cardiac dysfunction.
Initially, healthy pregnant patients who agree to participate in the study will be cited, after signing the informed consent, in order to evaluate the normal fetal cardiac function and see how it is modified in the different weeks of gestation.
To do this, a fetal echocardiography will be performed by the investigators at week 24, 28, 32 and 36 of pregnancy, using the aCMQ-Strain method.
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
- 是
入选标准
- •Patients older than 18 years
- •Pregnant women> 20 weeks gestation
- •Understand and accept the study procedures and sign an informed consent.
排除标准
- •Not being able to understand the nature of the study and / or the procedures to be followed.
- •Not signing informed consent
- •Under 18 years of age
- •Not pregnant
结局指标
主要结局
Changes in the shortening of cardiac fibers during cardiac cycle
时间窗: At 24, 28, 32 and 36 weeks of gestation
Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification)
次要结局
未报告次要终点