Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05685849
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-01-05
Brief Title:
Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease
Sponsor:
First Hospital of China Medical University
Organization:
First Hospital of China Medical University
Study Overview
Official Title:
Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Diseasea Prospective Multicenter Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Chinas 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None