Normal Reference Value for Echocardiography in Chinese Han Pregnancies

Recruiting

• Conditions: Pregnancy

• Registration Number: NCT05547841
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

The First Hospital of China Medical University initiated a multi-center study on the reference range of echocardiography in Chinese Han Pregnancies to determine the reference range of echocardiography in the pregnant population and to promote the clinical application of echocardiography in the pregnant population, thereby offering the value of early evaluation and early diagnosis for cardiac structure and function in the pregnant population.

Detailed Description

During normal pregnancy, the cardiovascular system of pregnant women will undergo significant adaptive changes in response to the growth of the uterus, fetus and placenta. Cardiac output and plasma volume will increase by 40% to 50% compared with non-pregnancy. The heart rate continues to increase, while the blood pressure decreases in the first and second trimesters and increases in the third trimester. The heart structure of pregnant women also remodels during pregnancy and the inner diameter of the cardiac cavity and myocardial mass increase. The above changes usually return to pre-pregnancy levels within 3-6 months after delivery. Pregnancy can change hemodynamics and cardiac structure, thereby causing corresponding changes in maternal cardiac function.Therefore, it is very important to closely monitor the changes of pregnant women's cardiac structure and function during pregnancy to assess their adaptive changes.

In addition, the incidence of cardiovascular disease in pregnancy is 1-4% worldwide, and about 15% of maternal deaths are caused by complications related to cardiovascular diseases during pregnancy. In China, the proportion of maternal deaths caused by cardiovascular diseases during pregnancy is increasing yearly and cardiovascular diseases during pregnancy have become the primary cause of death for critically ill pregnant women. Previous studies have shown that common complications during pregnancy, such as gestational hypertension and diabetes, can also alter maternal heart function. Therefore, early detection of changes in left ventricular systolic function of pregnant women during pregnancy and after childbirth, timely treatment and early evaluation of treatment efficacy can greatly reduce their mortality.

Echocardiography is the preferred method for cardiac examination during pregnancy, because of its safe and convenient, and has no radiation risk to the mother and fetus. It can accurately and quickly measure and evaluate the size of the pregnant woman's heart cavity, hemodynamic changes and cardiac function, and reflect the adaptive changes. Continuous observation at different stages of pregnancy and postpartum can deeply reveal the changing of cardiac structure and function. However, due to the adaptive changes during pregnancy, the reference value of normal adult echocardiography cannot be directly applied to pregnant women in clinical practice. At present, there is still a lack of normal reference value of echocardiography for pregnancies in clinical practice.

In conclusion, in order to assess the cardiac changes of pregnancies more comprehensively and accurately, and find the pathological changes caused by cardiovascular diseases during pregnancy timely, it is urgent to establish the normal reference value of echocardiography in pregnancies. The purpose of this study is to establish the normal reference value range of echocardiography in Chinese Han pregnancies in different pregnancy periods and early postpartum period, and to explore the influencing factors of changes with gestational age.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09
• Primary Completion: 2023-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

• Han nationality;
• 18-45 years old;
• Basal body mass index before pregnancy < 30 kg/m2;
• Normal blood pressure (139-90/89-60 mmHg);
• No history of cardiovascular and respiratory diseases;
• No abnormal findings in the physical examination of the cardiovascular and respiratory systems;
• Normal results in blood, urine, fasting blood glucose, blood lipids, liver and kidney function, thyroid function and electrocardiogram;
• Echocardiography shows normal cardiac function with no structural heart diseases;
• No use of medications that affect the cardiovascular system.

Exclusion Criteria

• Anemia (hemoglobin < 90 g/L);
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of echocardiographic parameters in Chinese Han pregnancies	From 11 weeks of gestation to 3-6 months postpartum	To establish the normal reference range for echocardiography in Chinese Han pregnancies in different pregnancy periods.

Secondary Outcome Measures

Name	Time	Method
Measurement of left ventricular systolic and diastolic function using echocardiography	From 11 weeks of gestation to 3-6 months postpartum	To establish the normal reference range of cardiac function for echocardiography in Chinese Han pregnancies in different pregnancy periods.

Trial Locations

Locations (34)

Chongqing Fifth People's Hospital; 🇨🇳 Chongqing, Chongqing, China

Chongqing Banan District People's Hospital; 🇨🇳 Chongqing, Chongqing, China

Chongqing Qianjiang District Central Hospital; 🇨🇳 Chongqing, Chongqing, China

Hainan Women and Children's Medical Center; 🇨🇳 Haikou, Hainan, China

Jiamusi Central Hospital; 🇨🇳 Jiamusi, Heilongjiang, China

Nanyang First People's Hospital; 🇨🇳 Nanyang, Henan, China

The Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The Center Hospital of Wuhan; 🇨🇳 Wuhan, Hubei, China

Maternal and Child Health Care Hospital Hubei; 🇨🇳 Wuhan, Hubei, China

Jilin Provincial Women and Children Health Hospital; 🇨🇳 Changchun, Jilin, China

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