Clinical trial NCT05685849: Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease
Official title: Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Keywords: Pregnancy
Cardiovascular disease
Cardiac function
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes:
measure: left ventricular global longitudinal strain
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Other outcomes:
Locations:
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Dalian
country: China
facility: Dalian Municipal Women and Children's Medical Center
state: Liaoning
city: Jinzhou
country: China
facility: Women And Children's Hospital of Jinzhou
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Maternity And Child Health Hospital
state: Liaoning
city: Shenyang
country: China
facility: the First Hospital of China Medical Univeristy
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: ShaanXi Province People's Hospital
state: Shaanxi
city: Weifang
country: China
facility: Weifang Maternal and Child Health Hospital
state: Shandong
city: Kunming
country: China
facility: Yunnan Maternal And Child Health Care Hospital
state: Yunnan
Study officials:
affiliation: First Hospital of China Medical University
name: Chunyan Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: