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临床试验/NCT05685849
NCT05685849招募中不适用

Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease:a Prospective, Multicenter, Clinical Trial

First Hospital of China Medical University10 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
10
主要终点
Left ventricular ejection fraction

研究概览

简要总结

The First Affiliated Hospital of China Medical University initiated a multi-center study to evaluate the changes of maternal fetal heart structure and function in pregnancies with cardiovascular disease by echocardiography, to explore the impact of cardiovascular disease on maternal fetal heart, so as to provide an important reference for obstetric pregnancy risk stratification and management.

详细描述

Globally, the incidence rate of pregnancy with cardiovascular disease is about 1-4%, and about 15% of maternal deaths are caused by pregnancy with cardiovascular disease related complications. With the opening of China's three children policy and the increase of older mothers, the proportion of maternal deaths caused by pregnancy combined with cardiovascular disease has increased year by year, which has become the primary cause of death of critically ill pregnancies in China. In addition, maternal cardiovascular disease is also the cause of fetal growth and development, cardiac structure abnormalities, and myocardial function damage. Therefore, early sensitive detection of changes in maternal and fetal cardiac structure and function during pregnancy, accurate risk assessment of pregnancy, detailed risk stratification, timely intervention and early evaluation of therapeutic efficacy can greatly reduce maternal mortality and ensure maternal and fetal safety.

Echocardiography is the preferred method for maternal fetal heart examination during pregnancy, because it is safe and convenient, and has no radiation risk to pregnancies and fetus. It can accurately and quickly measure and evaluate cardiac cavity size, hemodynamic changes and cardiac function, and can timely detect changes in the structure and function of pregnancies and fetuses at an early stage, and conduct continuous follow-up and close monitoring in different periods of pregnancy. In recent years, most of the domestic and foreign studies on the evaluation of echocardiography in pregnancy with cardiovascular disease are single center, small sample studies, mostly for a single disease, and the follow-up time is short. Some research results are contradictory and controversial, which can not accurately reflect the maternal fetal heart changes in pregnancy with cardiovascular disease. Therefore, it is urgent to conduct a large sample, multi-center study on the evaluation of cardiovascular disease in pregnancy by echocardiography in order to provide important reference and value for the stratification and management of pregnancy risk.

In conclusion, this study used echocardiography to evaluate the changes of maternal and fetal cardiac structure and function in pregnancies with cardiovascular disease, and to explore the impact of cardiovascular disease on maternal and fetal cardiac structure and function, so as to provide an important reference for obstetric pregnancy risk stratification and management, and help clinical monitoring and management of pregnancy with cardiovascular disease.

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
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women in the first trimester;
  • 20-45 years;
  • Complicated with cardiovascular diseases (mainly including congenital heart disease, aortic disease, valvular heart disease, coronary artery disease, cardiomyopathy, arrhythmia, hypertension, venous thromboembolism and other cardiovascular diseases).

排除标准

  • Other serious diseases of the immune, respiratory, digestive, nervous, urinary, blood, endocrine and other systems;
  • The poor quality of ultrasound images cannot meet the requirements of parameter measurement and analysis.

结局指标

主要结局

Left ventricular ejection fraction

时间窗: From 11 weeks of gestation to 3-6 months postpartum

To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease

次要结局

  • left ventricular global longitudinal strain(From 11 weeks of gestation to 3-6 months postpartum)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunyan Ma

Chief of Cardiovascular Ultrasound

First Hospital of China Medical University

研究点 (10)

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