Evaluation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease
Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial
1 other identifier
observational
200
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
January 5, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedFebruary 22, 2024
February 1, 2024
2.1 years
January 5, 2023
February 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular ejection fraction
To Evaluate of the changes of maternal cardiac systolic function in pregnancies with cardiovascular disease
From 11 weeks of gestation to 3-6 months postpartum
Secondary Outcomes (1)
left ventricular global longitudinal strain
From 11 weeks of gestation to 3-6 months postpartum
Study Arms (1)
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.
Interventions
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
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.
You may qualify if:
- Pregnant women in the first trimester；
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, 116033, China
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, 121000, China
Shenyang Maternity And Child Health Hospital
Shenyang, Liaoning, 110000, China
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, 110000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
ShaanXi Province People's Hospital
Xi'an, Shaanxi, 710068, China
Weifang Maternal and Child Health Hospital
Weifang, Shandong, 261011, China
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, 650051, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunyan Ma, MD
First Hospital of China Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Cardiovascular Ultrasound
Study Record Dates
First Submitted
January 5, 2023
First Posted
January 17, 2023
Study Start
January 1, 2023
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
February 22, 2024
Record last verified: 2024-02