PregnancyNCT05547841
Normal Reference Value for Echocardiography in Chinese Han Pregnancies
An observational study of Pregnancy, run by First Hospital of China Medical University at 34 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Echocardiography acquisition
- Type of treatment
- Medical device
- How many people
- 680 participants
- Where
- 34 sitesChina
- Study dates
- 1 Sep 2022to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Jilin Provincial Women and Children Health Hospital
Changchun, Jilin, 130012
Lili Zhang, MD, +86 13756150838, 602826349@qq.com
- Recruiting
Chongqing Fifth People's Hospital
Chongqing, Chongqing Municipality, 400000
Zhiwei He, Master, +86 13983408047, 403016330@qq.com
- Recruiting
Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality, 401320
Lili Hong, Master, +86 13996201786, 451951415@qq.com
- Recruiting
Chongqing Qianjiang District Central Hospital
Chongqing, Chongqing Municipality, 409000
Wei Guo, Master, +86 13996909666, 406548331@qq.com
- Recruiting
Dalian Friendship Hospital
Dalian, Liaoning, 116001
Bo Zhang, MD, +86 15840694167, zb781031dl@hotmail.com
- Recruiting
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, 116033
Yan Liu, PhD, +86 13354072780, wenfengcmu@yeah.net
- Recruiting
General Hospital of Fushun Mining Bureau
Fushun, Liaoning, 113000
Chunfeng Wang, 13352139456
- Recruiting
Hainan Women and Children's Medical Center
Haikou, Hainan, 570312
Shibin Lin, MD, +86 13976736929, 14393799@qq.com
- Recruiting
Heze Municipal Hospital
Heze, Shandong, 274000
Huili Fan, MD, +86 19953030992, wydfhl@163.com
- Recruiting
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002
Xin Yang, PhD, +86 15331879588, 1305987946@qq.com
- Recruiting
Jilin People's Hospital
Jilin City, Jilin, 132001
Xianzhi Wang, Master, +86 18104423461, 1069302604@qq.com
- Recruiting
Jilin Central General Hospital
Jilin City, Jilin, 132011
Bing Gong, MD, +86 15543430477, 767384287@qq.com
- Recruiting
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, 121000
Xuezhu Shao, Master, +86 18904169688, jzsxz6088@163.com
- Recruiting
the First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning
Yuhong Li, Ph.D
- Recruiting
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, 650051
Lixian Yang, Master, +86 15687890698, 34512088@qq.com
- Recruiting
Nanyang First People's Hospital
Nanyang, Henan, 473000
Feng Zhou, MD
- Recruiting
Panzhihua Maternal and Child Hospital
Panzhihua, Sichuan, 623000
Junling Shen, MD, +86 18982303299, 544193695@qq.com
- Recruiting
Shenyang Maternity And Child Health Hospital
Shenyang, Liaoning, 110000
Yunping Guan, MD, +86 18512431616, fygyp2008@sina.com
Jinmei Gao, MD, +86 13555858947, gjmcy@163.com
- Recruiting
Shenyang Women's and Children's Hospital
Shenyang, Liaoning, 110000
Danyang Song, 18540030821
- Recruiting
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, 110000
Chunyan Ma, MD, +8613998816448, mcy_echo@163.com
Chunyan Ma, MD
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Weidong Ren, Ph.D
- Recruiting
Siping Women and Infants Hospital
Siping, Jilin, 136000
Wei Li, Master, +86 18504340022, spfylw@163.com
- Recruiting
Tieling Women's And Children's Hospital
Tieling, Liaoning, 112000
Shuang Xu, Master, +86 13464190066, xushuang@163.com
- Recruiting
Weifang Maternal and Child Health Hospital
Weifang, Shandong, 261011
Chunxia Wang, MD, +86 13793655998, 13793655998@163.com
- Recruiting
The Center Hospital of Wuhan
Wuhan, Hubei, 430014
Jianxin Liu, PhD, +86 13647237661, aljxuv@sina.com
- Recruiting
Maternal and Child Health Care Hospital Hubei
Wuhan, Hubei, 430070
Sheng Zhao, PhD, +86 13667190934, 1015568495@qq.com
- Recruiting
ShaanXi Province People's Hospital
Xi'an, Shaanxi, 710068
Xiangping Guan, Master, +86 13991979638, 13991979638@139.com
- Recruiting
Northwest Women's and Children's Hospital
Xi’an, Shanxi, 710068
Xinru Gao, 13152170136
- Recruiting
Qinghai Provincial Maternal and Child Health Hospital
Xining, Qinghai, 810000
Yingfang Wa, Master, +86 13897262492, qh2556@163.com
- Recruiting
Yaan People's Hospital
Ya'an, Sichuan, 625000
Dan Tian, Master, +86 18908160262, 806984930@qq.com
- Recruiting
Yanji Maternal and Infant Hospital
Yanji, Jilin, 133001
Yingchun Cui, Master, +86 13704436465, 1619565837@qq.com
- Recruiting
Ningxia Maternal And Child Health Care Hospital
Yinchuan, Ningxia, 750000
Xueqin Ji, MD, +86 13995317304, jinian54@163.com
- Recruiting
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Hezhou Li, PhD, +86 13838550002, lihezhou67@126.com
- Recruiting
ZiBo Central Hospital
Zibo, Shandong, 255020
Xiaoguang Huo, MD, +86 18653399919, 18653399919@163.cm
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Echocardiography acquisition
- Keywords
- Pregnancy, Echocardiography, Cardiac function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography acquisitionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Echocardiography acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of echocardiographic parameters in Chinese Han pregnancies
To establish the normal reference range for echocardiography in Chinese Han pregnancies in different pregnancy periods.
Measured: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes (1)
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.
Measured: From 11 weeks of gestation to 3-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Sep 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Ma, First Hospital of China Medical University
- Investigators
- Chunyan Ma, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547841
- Sponsor's protocol ID
- NO-REVAE-01
- Status last verified
- Jan 2023
- First submitted
- 16 Sep 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Reference Value for Echocardiography in Chinese Han Pregnancies: a Prospective, Multicenter, Clinical Trial
- ClinicalTrials.gov ID
- NCT05547841
- Acronym / sponsor ID
- NO-REVAE-01
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Echocardiography, Cardiac function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | – | Device: Echocardiography acquisitionA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography acquisitionEchocardiography 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). | Device | Trial group |
Primary outcome
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.
1 secondary outcome
Measurement of left ventricular systolic and diastolic function using echocardiography
Time frame: From 11 weeks of gestation to 3-6 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunyan Ma, MD principal investigator
First Hospital of China Medical University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by First Hospital of China Medical University at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunyan Ma, MD (+86 13998816448, mcy_echo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of echocardiographic parameters in Chinese Han pregnancies (time frame: From 11 weeks of gestation to 3-6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.