Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Other serious diseases of the immune, respiratory, digestive, nervous, urinary, blood, endocrine and other systems; Tumors; The poor quality of ultrasound images cannot meet the requirements of parameter measurement and analysis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trial group<br>A total of 200 pregnant women in the first trimester (gestational age of 6-13 weeks+6 days), who had cardiovascular disease and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 10 centers, with 20 cases in each center. | Device: Echocardiography<br>* Maternal and fetal echocardiography：Time points for heart image acquisition in pregnant women: As per the Guidelines for Pre-pregnancy and Pregnancy Health Care (2018) formulated by the Obstetrics Group of the Gynecology Branch of the Chinese Medical Association, a total of five echocardiographic examinations will be performed in the first trimester(11-14 weeks of gestation), the second trimester(20-24 weeks of gestation), the third trimester(29-32 weeks of gestation), prenatal term (37-40 weeks of gestation), and 3-6 months after delivery. Time points for fetal heart image acquisition: Fetal heart images will be collected in the second trimester(20 to 24 weeks of gestation).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction | To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease | From 11 weeks of gestation to 3-6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular global longitudinal strain | To Evaluate of the subclinical changes of maternal cardiac systolic function in pregnancies with cardiovascular disease | From 11 weeks of gestation to 3-6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Cardiovascular disease, Cardiac function