Normal Reference Value for Echocardiography in Chinese Han Pregnancies

January 5, 2023 updated by: Chunyan Ma, First Hospital of China Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

680

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing Fifth People's Hospital
        • Contact:
      • Chongqing, Chongqing, China, 401320
        • Recruiting
        • Chongqing Banan District People's Hospital
        • Contact:
      • Chongqing, Chongqing, China, 409000
        • Recruiting
        • Chongqing Qianjiang District Central Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570312
        • Recruiting
        • HaiNan Women and Children's Medical Center
        • Contact:
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154002
        • Recruiting
        • Jiamusi Central Hospital
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473000
        • Recruiting
        • Nanyang First People's Hospital
        • Contact:
          • Feng Zhou, MD
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The Third Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430014
        • Recruiting
        • The Center Hospital of WuHan
        • Contact:
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Maternal and Child Health Care Hospital Hubei
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130012
        • Recruiting
        • Jilin Provincial Women and Children Health Hospital
        • Contact:
      • Jilin, Jilin, China, 132011
        • Recruiting
        • Jilin Central General Hospital
        • Contact:
      • Jilin, Jilin, China, 132001
        • Recruiting
        • Jilin People's Hospital
        • Contact:
      • Siping, Jilin, China, 136000
        • Recruiting
        • Siping Women and Infants Hospital
        • Contact:
      • Yanji, Jilin, China, 133001
        • Recruiting
        • Yanji Maternal and Infant Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Recruiting
        • Dalian Friendship Hospital
        • Contact:
      • Dalian, Liaoning, China, 116033
        • Recruiting
        • Dalian Municipal Women and Children's Medical Center
        • Contact:
      • Fushun, Liaoning, China, 113000
        • Recruiting
        • General Hospital of Fushun Mining Bureau
        • Contact:
          • Chunfeng Wang
          • Phone Number: 13352139456
      • Jinzhou, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital Of Jinzhou Medical University
        • Contact:
          • Yuhong Li, Ph.D
      • Jinzhou, Liaoning, China, 121000
        • Recruiting
        • Women And Children's Hospital of Jinzhou
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Weidong Ren, Ph.D
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang Maternity And Child Health Hospital
        • Contact:
        • Contact:
          • Jinmei Gao, MD
          • Phone Number: +86 13555858947
          • Email: gjmcy@163.com
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang women's and children's hospital
        • Contact:
          • Danyang Song
          • Phone Number: 18540030821
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • the First Hospital of China Medical Univeristy
        • Contact:
        • Principal Investigator:
          • Chunyan Ma, MD
      • Tieling, Liaoning, China, 112000
        • Recruiting
        • Tieling Women's And Children's Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • Ningxia Maternal And Child Health Care Hospital
        • Contact:
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Qinghai Provincial Maternal and Child Health Hospital
        • Contact:
          • Yingfang Wa, Master
          • Phone Number: +86 13897262492
          • Email: qh2556@163.com
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • ShaanXi Province People's Hospital
        • Contact:
    • Shandong
      • Heze, Shandong, China, 274000
        • Recruiting
        • Heze Municipal Hospital
        • Contact:
      • Weifang, Shandong, China, 261011
        • Recruiting
        • Weifang Maternal and Child Health Hospital
        • Contact:
      • Zibo, Shandong, China, 255020
        • Recruiting
        • Zibo central Hospital
        • Contact:
    • Shanxi
      • Xi'an, Shanxi, China, 710068
        • Recruiting
        • Northwest Women's and Children's Hospital
        • Contact:
          • Xinru Gao
          • Phone Number: 13152170136
    • Sichuan
      • Panzhihua, Sichuan, China, 623000
        • Recruiting
        • Panzhihua Maternal and Child Hospital
        • Contact:
      • Ya'an, Sichuan, China, 625000
        • Recruiting
        • Yaan People's Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650051
        • Recruiting
        • Yunnan Maternal And Child Health Care Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trial group
A total of 680 singleton pregnant women in the first trimester (gestational age of 6-13 weeks + 6 days), 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of echocardiographic parameters in Chinese Han pregnancies
Time Frame: 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.
From 11 weeks of gestation to 3-6 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of left ventricular systolic and diastolic function using echocardiography
Time Frame: 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.
From 11 weeks of gestation to 3-6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Investigators

  • Principal Investigator: Chunyan Ma, MD, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 5, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NO-REVAE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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