Normal Reference Value for Echocardiography in Chinese Han Pregnancies

Last updated: January 5, 2023
Sponsor: First Hospital of China Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT05547841
NO-REVAE-01
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 respiratorysystems;
  • Normal results in blood, urine, fasting blood glucose, blood lipids, liver and kidneyfunction, thyroid function and electrocardiogram;
  • Echocardiography shows normal cardiac function with no structural heart diseases;
  • No use of medications that affect the cardiovascular system.

Exclusion

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 parametermeasurement and analysis.

Study Design

Total Participants: 680
Study Start date:
September 01, 2022
Estimated Completion Date:
August 30, 2024

Study 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.

Connect with a study center

  • Chongqing Banan District People's Hospital

    Chongqing, Chongqing 401320
    China

    Active - Recruiting

  • Chongqing Fifth People's Hospital

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

  • Chongqing Qianjiang District Central Hospital

    Chongqing, Chongqing 409000
    China

    Active - Recruiting

  • Hainan Women and Children's Medical Center

    Haikou, Hainan 570312
    China

    Active - Recruiting

  • Jiamusi Central Hospital

    Jiamusi, Heilongjiang 154002
    China

    Active - Recruiting

  • Nanyang First People's Hospital

    Nanyang, Henan 473000
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Maternal and Child Health Care Hospital Hubei

    Wuhan, Hubei 430070
    China

    Active - Recruiting

  • The Center Hospital of Wuhan

    Wuhan, Hubei 430014
    China

    Active - Recruiting

  • Jilin Provincial Women and Children Health Hospital

    Changchun, Jilin 130012
    China

    Active - Recruiting

  • Jilin Central General Hospital

    Jilin, Jilin 132011
    China

    Active - Recruiting

  • Jilin People's Hospital

    Jilin, Jilin 132001
    China

    Active - Recruiting

  • Siping Women and Infants Hospital

    Siping, Jilin 136000
    China

    Active - Recruiting

  • Yanji Maternal and Infant Hospital

    Yanji, Jilin 133001
    China

    Active - Recruiting

  • Dalian Friendship Hospital

    Dalian, Liaoning 116001
    China

    Active - Recruiting

  • Dalian Municipal Women and Children's Medical Center

    Dalian, Liaoning 116033
    China

    Active - Recruiting

  • General Hospital of Fushun Mining Bureau

    Fushun, Liaoning 113000
    China

    Active - Recruiting

  • Women And Children's Hospital of Jinzhou

    Jinzhou, Liaoning 121000
    China

    Active - Recruiting

  • the First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Shenyang Maternity And Child Health Hospital

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Shenyang Women's and Children's Hospital

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • the First Hospital of China Medical Univeristy

    Shenyang, Liaoning 110000
    China

    Active - Recruiting

  • Tieling Women's And Children's Hospital

    Tieling, Liaoning 112000
    China

    Active - Recruiting

  • Ningxia Maternal And Child Health Care Hospital

    Yinchuan, Ningxia 750000
    China

    Active - Recruiting

  • Qinghai Provincial Maternal and Child Health Hospital

    Xining, Qinghai 810000
    China

    Active - Recruiting

  • ShaanXi Province People's Hospital

    Xi'an, Shaanxi 710068
    China

    Active - Recruiting

  • Heze Municipal Hospital

    Heze, Shandong 274000
    China

    Active - Recruiting

  • Weifang Maternal and Child Health Hospital

    Weifang, Shandong 261011
    China

    Active - Recruiting

  • ZiBo Central Hospital

    Zibo, Shandong 255020
    China

    Active - Recruiting

  • Northwest Women's and Children's Hospital

    Xi'an, Shanxi 710068
    China

    Active - Recruiting

  • Panzhihua Maternal and Child Hospital

    Panzhihua, Sichuan 623000
    China

    Active - Recruiting

  • Yaan People's Hospital

    Ya'an, Sichuan 625000
    China

    Active - Recruiting

  • Yunnan Maternal And Child Health Care Hospital

    Kunming, Yunnan 650051
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.