Clinical trial NCT05547841: Normal Reference Value for Echocardiography in Chinese Han Pregnancies
Official title: Normal Reference Value for Echocardiography in Chinese Han Pregnancies: a Prospective, Multicenter, Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy
Echocardiography
Cardiac function
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 680
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 680 singleton pregnant women in the first trimester, who had normal results in various examinations and experienced regular obstetric examinations throughout the pregnancy, were selected from the obstetric outpatients in 34 centers, with 20 cases in each center.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of echocardiographic parameters in Chinese Han pregnancies
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes:
measure: Measurement of left ventricular systolic and diastolic function using echocardiography
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Fifth People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Banan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Qianjiang District Central Hospital
state: Chongqing
city: Haikou
country: China
facility: Hainan Women and Children's Medical Center
state: Hainan
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The Center Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Maternal and Child Health Care Hospital Hubei
state: Hubei
city: Changchun
country: China
facility: Jilin Provincial Women and Children Health Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin People's Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin Central General Hospital
state: Jilin
city: Siping
country: China
facility: Siping Women and Infants Hospital
state: Jilin
city: Yanji
country: China
facility: Yanji Maternal and Infant Hospital
state: Jilin
city: Dalian
country: China
facility: Dalian Friendship Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Women and Children's Medical Center
state: Liaoning
city: Fushun
country: China
facility: General Hospital of Fushun Mining Bureau
state: Liaoning
city: Jinzhou
country: China
facility: Women And Children's Hospital of Jinzhou
state: Liaoning
city: Jinzhou
country: China
facility: the First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Maternity And Child Health Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Women's and Children's Hospital
state: Liaoning
city: Shenyang
country: China
facility: the First Hospital of China Medical Univeristy
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Tieling
country: China
facility: Tieling Women's And Children's Hospital
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Maternal And Child Health Care Hospital
state: Ningxia
city: Xining
country: China
facility: Qinghai Provincial Maternal and Child Health Hospital
state: Qinghai
city: Xi'an
country: China
facility: ShaanXi Province People's Hospital
state: Shaanxi
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Maternal and Child Health Hospital
state: Shandong
city: Zibo
country: China
facility: ZiBo Central Hospital
state: Shandong
city: Xi'an
country: China
facility: Northwest Women's and Children's Hospital
state: Shanxi
city: Panzhihua
country: China
facility: Panzhihua Maternal and Child Hospital
state: Sichuan
city: Ya'an
country: China
facility: Yaan People's Hospital
state: Sichuan
city: Kunming
country: China
facility: Yunnan Maternal And Child Health Care Hospital
state: Yunnan
Study officials:
affiliation: First Hospital of China Medical University
name: Chunyan Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: