Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease
NCT ID: NCT05685849
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-01-01
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Trial group
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.
Echocardiography
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).
Interventions
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Echocardiography
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumors;
* The poor quality of ultrasound images cannot meet the requirements of parameter measurement and analysis.
20 Years
45 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
Responsible Party
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Chunyan Ma
Chief of Cardiovascular Ultrasound
Principal Investigators
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Chunyan Ma, MD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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Jiamusi Central Hospital
Jiamusi, Heilongjiang, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, China
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, China
Shenyang Maternity And Child Health Hospital
Shenyang, Liaoning, China
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
ShaanXi Province People's Hospital
Xi'an, Shaanxi, China
Weifang Maternal and Child Health Hospital
Weifang, Shandong, China
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Weidong Ren, Ph.D
Role: primary
Other Identifiers
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MF-CAD
Identifier Type: -
Identifier Source: org_study_id
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