Normal Reference Value for Echocardiography in Chinese Han Pregnancies
NCT ID: NCT05547841
Last Updated: 2023-01-09
Study Results
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Basic Information
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UNKNOWN
680 participants
OBSERVATIONAL
2022-09-01
2024-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
Responsible Party
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Chunyan Ma
Chief of Cardiovascular Ultrasound
Principal Investigators
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Chunyan Ma, MD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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Chongqing Fifth People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality, China
Chongqing Qianjiang District Central Hospital
Chongqing, Chongqing Municipality, 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
Jilin People's Hospital
Jilin, Jilin, China
Jilin Central General Hospital
Jilin, Jilin, China
Siping Women and Infants Hospital
Siping, Jilin, China
Yanji Maternal and Infant Hospital
Yanji, Jilin, 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
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, China
the First Affiliated Hospital of Jinzhou Medical University
Jinzhou, 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
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Tieling Women's And Children's Hospital
Tieling, Liaoning, China
Ningxia Maternal And Child Health Care Hospital
Yinchuan, Ningxia, China
Qinghai Provincial Maternal and Child Health Hospital
Xining, Qinghai, China
ShaanXi Province People's Hospital
Xi'an, Shaanxi, China
Heze Municipal Hospital
Heze, Shandong, China
Weifang Maternal and Child Health Hospital
Weifang, Shandong, China
ZiBo Central Hospital
Zibo, Shandong, China
Northwest Women's and Children's Hospital
Xi’an, Shanxi, China
Panzhihua Maternal and Child Hospital
Panzhihua, Sichuan, China
Yaan People's Hospital
Ya'an, Sichuan, China
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Feng Zhou, MD
Role: primary
Chunfeng Wang
Role: primary
Yuhong Li, Ph.D
Role: primary
Danyang Song
Role: primary
Weidong Ren, Ph.D
Role: primary
Xinru Gao
Role: primary
Other Identifiers
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NO-REVAE-01
Identifier Type: -
Identifier Source: org_study_id
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