Standardization Of A Novel Method To Assess Fetal Cardiac Function: Myocardial Deformation Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Inter-observer variability of institutional imaging and analysis protocol
研究概览
简要总结
Cardiac disease in children may start early in life and evidence of cardiac disease can be seen during prenatal life. A variety of diseases diagnosed during fetal life can put children at risk for cardiac disease. The accurate assessment of cardiac function is important in these patients. A type of imaging scan called "fetal echocardiogram" is used to measure the contractility or squeeze of the heart. The fetal echocardiogram is a painless test and completely non-invasive.
This study aims to recruit women and fetuses to determine if this imaging scan can be used throughout the pregnancy to measure heart squeeze and develop normal values to help doctors better diagnose fetuses who may have cardiac disease before they are born.
详细描述
The subject will have to complete 6 fetal echocardiograms. A fetal echocardiogram is picture of the unborn baby's heart in motion made by bouncing sound waves off the heart and recording the echo. The procedure will be very similar to the ultrasounds that the subject is already receiving as part of her prenatal care.
The scans will start at week 20 of the subject's pregnancy and repeat every 3 weeks until week 38 of birth (whichever occurs first). The appointments will last approximately 30 minutes each and will be performed by one of two sonographers trained specifically in fetal echocardiography. One additional echocardiogram will be performed on the infant after birth, within the first two months of life. In addition to the scans, study staff will access the subject's medical record to collect information such as: age, ethnicity, race, medical history and health insurance status.
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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient at the obstetrics clinic at Texas Children's Hospital Pavilion for Women at the time of their second trimester screening ultrasound
- •Fetus must have no recognizable disease at the second trimester screening ultrasound
- •Willing to participate in a total of 5 fetal echocardiograms and one within 2 months after delivery
- •English or Spanish literacy
- •A four chamber view of the heart must be visible upon screening examination
- •No fetal anatomic or growth abnormalities suspected on screening examination.
排除标准
- •Subjects that meet the cutoff point for maternal obesity (BMI>30) and have identified risk factors for fetal cardiac dysfunction as determined by medical team.
结局指标
主要结局
Inter-observer variability of institutional imaging and analysis protocol
时间窗: 1 year
Determine the inter-observer variability of our imaging and analysis protocol for the measurement of fetal myocardial deformation throughout gestation and after birth. The investigator will use the paired t-test to compare differences in measurement between the two observers at each time point.
次要结局
- Normative reference ranges for various measures of myocardial deformation(1 year)
研究者
Ricardo H Pignatelli
Assistant Professor
Baylor College of Medicine