Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05685849 |
| Other study ID # |
MF-CAD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
January 31, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
First Hospital of China Medical University |
| Contact |
Chunyan Ma, MD |
| Phone |
+86 13998816448 |
| Email |
mcy_echo[@]163.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
