Normal Reference Value for Echocardiography in Chinese Han Pregnancies

Pregnancy Clinical Trial

Official title:

Normal Reference Value for Echocardiography in Chinese Han Pregnancies: a Prospective, Multicenter, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547841
• Other study ID #: NO-REVAE-01
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2023
• Source: First Hospital of China Medical University
• Contact: Chunyan Ma, MD
• Phone: +86 13998816448
• Email: mcy_echo[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Echocardiography acquisition
Echocardiography examination of all participants using PHILIPS. 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 six 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), 6 weeks 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).

Locations

Country	Name	City	State
China	Jilin Provincial Women and Children Health Hospital	Changchun	Jilin
China	Chongqing Banan District People's Hospital	Chongqing	Chongqing
China	Chongqing Fifth People's Hospital	Chongqing	Chongqing
China	Chongqing Qianjiang District Central Hospital	Chongqing	Chongqing
China	Dalian Friendship Hospital	Dalian	Liaoning
China	Dalian Municipal Women and Children's Medical Center	Dalian	Liaoning
China	General Hospital of Fushun Mining Bureau	Fushun	Liaoning
China	Hainan Women and Children's Medical Center	Haikou	Hainan
China	Heze Municipal Hospital	Heze	Shandong
China	Jiamusi Central Hospital	Jiamusi	Heilongjiang
China	Jilin Central General Hospital	Jilin	Jilin
China	Jilin People's Hospital	Jilin	Jilin
China	the First Affiliated Hospital of Jinzhou Medical University	Jinzhou	Liaoning
China	Women And Children's Hospital of Jinzhou	Jinzhou	Liaoning
China	Yunnan Maternal And Child Health Care Hospital	Kunming	Yunnan
China	Nanyang First People's Hospital	Nanyang	Henan
China	Panzhihua Maternal and Child Hospital	Panzhihua	Sichuan
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	Shenyang Maternity And Child Health Hospital	Shenyang	Liaoning
China	Shenyang Women's and Children's Hospital	Shenyang	Liaoning
China	the First Hospital of China Medical Univeristy	Shenyang	Liaoning
China	Siping Women and Infants Hospital	Siping	Jilin
China	Tieling Women's And Children's Hospital	Tieling	Liaoning
China	Weifang Maternal and Child Health Hospital	Weifang	Shandong
China	Maternal and Child Health Care Hospital Hubei	Wuhan	Hubei
China	The Center Hospital of Wuhan	Wuhan	Hubei
China	Northwest Women's and Children's Hospital	Xi'an	Shanxi
China	ShaanXi Province People's Hospital	Xi'an	Shaanxi
China	Qinghai Provincial Maternal and Child Health Hospital	Xining	Qinghai
China	Yaan People's Hospital	Ya'an	Sichuan
China	Yanji Maternal and Infant Hospital	Yanji	Jilin
China	Ningxia Maternal And Child Health Care Hospital	Yinchuan	Ningxia
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	ZiBo Central Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of echocardiographic parameters in Chinese Han pregnancies	To establish the normal reference range for echocardiography in Chinese Han pregnancies in different pregnancy periods.	From 11 weeks of gestation to 3-6 months postpartum
Secondary	Measurement of left ventricular systolic and diastolic function using echocardiography	To establish the normal reference range of cardiac function for echocardiography in Chinese Han pregnancies in different pregnancy periods.	From 11 weeks of gestation to 3-6 months postpartum