Evaluating heart health in pregnant women with cardiovascular disease

Valuation of Maternal Fetal Cardiac Structure and Function in Pregnancies With Cardiovascular Disease：a Prospective, Multicenter, Clinical Trial

This study looks at how heart problems in pregnant women affect their heart and their baby's heart during pregnancy to help keep both of them safe.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 20 Years to 45 Years
• Sex: Female
• Sponsor: First Hospital of China Medical University (Academic / other)
• Drugs / interventions: radiation
• Locations: 10 sites (Jiamusi, Heilongjiang and 9 other locations)
• Trial ID: NCT05685849 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the changes in maternal and fetal heart structure and function during pregnancies complicated by cardiovascular disease using echocardiography. The study will monitor pregnant women in their first trimester who have various cardiovascular conditions, providing critical insights into how these conditions affect both mother and fetus. By identifying early changes in cardiac function, the research seeks to improve risk assessment and management strategies for pregnant women with cardiovascular issues, ultimately aiming to reduce maternal mortality and ensure the safety of both mother and child.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 20-45 in their first trimester who have cardiovascular diseases.

Not a fit: Patients with serious diseases affecting other organ systems or those with tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management of pregnancies complicated by cardiovascular disease, enhancing maternal and fetal health outcomes.

How similar studies have performed: Other studies have shown success in using echocardiography for monitoring cardiac function in pregnant women, indicating that this approach is both established and beneficial.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Where this trial is running

Jiamusi, Heilongjiang and 9 other locations

• Jiamusi Central Hospital — Jiamusi, Heilongjiang, China (Recruiting)
• The Third Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Dalian Municipal Women and Children's Medical Center — Dalian, Liaoning, China (Recruiting)
• Women And Children's Hospital of Jinzhou — Jinzhou, Liaoning, China (Recruiting)
• Shenyang Maternity And Child Health Hospital — Shenyang, Liaoning, China (Recruiting)
• the First Hospital of China Medical Univeristy — Shenyang, Liaoning, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• ShaanXi Province People's Hospital — Xi'an, Shaanxi, China (Recruiting)
• Weifang Maternal and Child Health Hospital — Weifang, Shandong, China (Recruiting)
• Yunnan Maternal And Child Health Care Hospital — Kunming, Yunnan, China (Recruiting)

Study contacts

• Principal investigator: Chunyan Ma, MD — First Hospital of China Medical University
• Study coordinator: Chunyan Ma, MD

Conditions Pregnancy; Cardiovascular disease; Cardiac function