PregnancyNCT05685849
Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease
An observational study of Pregnancy, run by First Hospital of China Medical University at 10 sites in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 10 sitesChina
- Study dates
- 1 Jan 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, 116033
Yan Liu, PhD, +86 13354072780, wenfengcmu@yeah.net
- Recruiting
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002
Xin Yang, PhD, +86 15331879588, 1305987946@qq.com
- Recruiting
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, 121000
Xuezhu Shao, Master, +86 18904169688, jzsxz6088@163.com
- Recruiting
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, 650051
Lixian Yang, Master, +86 15687890698, 34512088@qq.com
- Recruiting
Shenyang Maternity And Child Health Hospital
Shenyang, Liaoning, 110000
Yunping Guan, MD, +86 18512431616, fygyp2008@sina.com
Jinmei Gao, MD, +86 13555858947, gjmcy@163.com
- Recruiting
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, 110000
Chunyan Ma, MD, +8613998816448, mcy_echo@163.com
Chunyan Ma, MD
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Weidong Ren, Ph.D
- Recruiting
Weifang Maternal and Child Health Hospital
Weifang, Shandong, 261011
Chunxia Wang, MD, +86 13793655998, 13793655998@163.com
- Recruiting
ShaanXi Province People's Hospital
Xi'an, Shaanxi, 710068
Xiangping Guan, Master, +86 13991979638, 13991979638@139.com
- Recruiting
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Hezhou Li, PhD, +86 13838550002, lihezhou67@126.com
About this study
Official title: Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Echocardiography
- Keywords
- Pregnancy, Cardiovascular disease, Cardiac function
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
Measured: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes (1)
left ventricular global longitudinal strain
To Evaluate of the subclinical changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
Measured: From 11 weeks of gestation to 3-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685849
- Sponsor's protocol ID
- MF-CAD
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial
- ClinicalTrials.gov ID
- NCT05685849
- Acronym / sponsor ID
- MF-CAD
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Cardiovascular disease, Cardiac function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | – | Device: EchocardiographyA 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyMaternal 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). | Device | Trial group |
Primary outcome
Left ventricular ejection fraction
Time frame: From 11 weeks of gestation to 3-6 months postpartum
To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
1 secondary outcome
left ventricular global longitudinal strain
Time frame: From 11 weeks of gestation to 3-6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Ma, MD principal investigator
First Hospital of China Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by First Hospital of China Medical University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Ma, MD (+86 13998816448, mcy_echo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: From 11 weeks of gestation to 3-6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.