PregnancyNCT05375123
Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies
An observational study of Pregnancy, run by First Hospital of China Medical University at 33 sites in China.
Trial summary
The First Affiliated Hospital of China Medical University initiated a multi-center study on the reference range of tissue motion tracking of mitral annulus displacement in Chinese Han singleton pregnancies to determine the reference range of tissue motion annular displacement (TMAD) in the pregnant population and to… 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?
- Ultrasound image acquisition
- Type of treatment
- Medical device
- How many people
- 660 participants
- Where
- 33 sitesChina
- Study dates
- 1 Jul 2022to 30 Jun 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 660 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 33 centers, with 20 cases in each center.
Who may be able to join
- Singleton pregnancy;
- 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;
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- 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.
Who cannot join
- Multiple pregnancy;
- 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
33 sites in 1 country.
33 sites in 1 country
China33 sites, 33 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
Maternity and Child Care Centers of Fujian Province
Fuzhou, Fujian, 350001
Min Liu, MD, +86 13003816669, liumin6669@163.com
- 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
Shandong Maternal and Child Health Hospital
Jinan, Shandong, 250014
Hong Yin, MD, +86 18053153367, 18053153367@163.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, 121001
Yuhong Li, PhD, +86 13940637604, yuhong_jiahui@163.com
- 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
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
Weidong Ren, PhD, +86 18940251657, renwd01@163.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
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, 110000
Chunyan Ma, MD, +8613998816448, mcy_echo@163.com
Chunyan Ma, MD
- 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
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: Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies: a Prospective, Multicenter, Clinical Trial
The First Affiliated Hospital of China Medical University initiated a multi-center study on the reference range of tissue motion tracking of mitral annulus displacement in Chinese Han singleton pregnancies to determine the reference range of tissue motion annular displacement (TMAD) in the pregnant population and to promote the clinical application of TMAD in the pregnant population, thereby offering new insights into the early evaluation and early diagnosis for cardiac 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. Adaptive changes in maternal cardiac function can be reflected through an accurate and rapid evaluation. Changes in maternal cardiac function can be continuously observed and analyzed during pregnancy and after delivery to uncover the changing law of maternal cardiac function.
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.
The Simpson's biplane method is currently used to measure left ventricular ejection fraction for clinical evaluation of left ventricular systolic function, which is especially available for patients without left ventricular geometric deformation. However, left ventricular ejection fraction cannot be sensitive to early changes in cardiac function. In recent years, two-dimensional longitudinal strain has been included for evaluating left ventricular systolic function. Myocardial longitudinal motion is responsible for maintaining 70% of normal cardiac function. Researchers believe that this method can sensitively detect early changes in left ventricular systolic function. However, the above two methods have high requirements on the quality of ultrasound images, which can clearly display the endocardium and epicardium based on good sound-transmitting conditions and good image quality. However, the image quality of pregnant women is often poor, so there is a decline in the detection accuracy.
Previous studies have shown that TMAD is independent of image quality and can effectively evaluate left ventricular systolic function and is an effective supplement to left ventricular ejection fraction and the overall longitudinal strain of the left ventricle. TMAD is a new technique for quantitative analysis of mitral annulus motion parameters. Three observation points are set on the septal side, lateral side and apex of the mitral annulus in the apical four-chamber view. The movement of the mitral annulus relative to the apex will be detected to obtain the lateral displacement of the mitral annulus septum (TMAD sep), the lateral displacement of the mitral annulus (TMAD lat), the mean displacement (TMADmid), and the mean displacement rate (TMADmidpt%). The left ventricular longitudinal systolic function will be then evaluated. TMAD only requires image acquisition from three sites and has low requirements on the quality of ultrasound images. Therefore, this measurement is simple, accurate and highly repeatable.
However, the TMAD reference value of normal healthy adults cannot be directly applied to pregnant women due to the hemodynamic changes during pregnancy. It is still necessary to establish the reference value of TMAD in pregnant women and explore its changes with gestational age, so as to provide simple, fast, accurate ultrasound parameters that do not depend on image quality for the evaluation of cardiac function during pregnancy.
The purpose of this study is to establish the reference range of TMAD parameters in Chinese Han singleton pregnancies in different pregnancy periods and early postpartum period and to explore the influencing factors of TMAD in singleton pregnancies.
- Conditions
- Pregnancy
- Being tested
- Ultrasound image acquisition
- Keywords
- Pregnancy, Left Ventricular Systolic Function, Tissue Motion Tracking of Mitral Annular Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound image acquisitionDevice
Echocardiography: left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement 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 (37-41 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 660 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 33 centers, with 20 cases in each center. Receives: Device: Ultrasound image acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method
To establish the reference range of TMADmid and TMADmidpt% in Chinese Han singleton pregnancies using the TMAD method.
Measured: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes (1)
Measurement of left ventricular systolic function using the Simpson's biplane method
Measurement of left ventricular ejection fraction measured by the Simpson's biplane method is a clinical standard
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 posted16 May 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 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
- 660 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
- NCT05375123
- Sponsor's protocol ID
- REVAW-TMAD-01
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2022
- Last updated
- 15 Jul 2022
- 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies: a Prospective, Multicenter, Clinical Trial
- ClinicalTrials.gov ID
- NCT05375123
- Acronym / sponsor ID
- REVAW-TMAD-01
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Left Ventricular Systolic Function, Tissue Motion Tracking of Mitral Annular Displacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 May 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 Affiliated Hospital of China Medical University initiated a multi-center study on the reference range of tissue motion tracking of mitral annulus displacement in Chinese Han singleton pregnancies to determine the reference range of tissue motion annular displacement (TMAD) in the pregnant population and to promote the clinical application of TMAD in the pregnant population, thereby offering new insights into the early evaluation and early diagnosis for cardiac 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. Adaptive changes in maternal cardiac function can be reflected through an accurate and rapid evaluation. Changes in maternal cardiac function can be continuously observed and analyzed during pregnancy and after delivery to uncover the changing law of maternal cardiac function.
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.
The Simpson's biplane method is currently used to measure left ventricular ejection fraction for clinical evaluation of left ventricular systolic function, which is especially available for patients without left ventricular geometric deformation. However, left ventricular ejection fraction cannot be sensitive to early changes in cardiac function. In recent years, two-dimensional longitudinal strain has been included for evaluating left ventricular systolic function. Myocardial longitudinal motion is responsible for maintaining 70% of normal cardiac function. Researchers believe that this method can sensitively detect early changes in left ventricular systolic function. However, the above two methods have high requirements on the quality of ultrasound images, which can clearly display the endocardium and epicardium based on good sound-transmitting conditions and good image quality. However, the image quality of pregnant women is often poor, so there is a decline in the detection accuracy.
Previous studies have shown that TMAD is independent of image quality and can effectively evaluate left ventricular systolic function and is an effective supplement to left ventricular ejection fraction and the overall longitudinal strain of the left ventricle. TMAD is a new technique for quantitative analysis of mitral annulus motion parameters. Three observation points are set on the septal side, lateral side and apex of the mitral annulus in the apical four-chamber view. The movement of the mitral annulus relative to the apex will be detected to obtain the lateral displacement of the mitral annulus septum (TMAD sep), the lateral displacement of the mitral annulus (TMAD lat), the mean displacement (TMADmid), and the mean displacement rate (TMADmidpt%). The left ventricular longitudinal systolic function will be then evaluated. TMAD only requires image acquisition from three sites and has low requirements on the quality of ultrasound images. Therefore, this measurement is simple, accurate and highly repeatable.
However, the TMAD reference value of normal healthy adults cannot be directly applied to pregnant women due to the hemodynamic changes during pregnancy. It is still necessary to establish the reference value of TMAD in pregnant women and explore its changes with gestational age, so as to provide simple, fast, accurate ultrasound parameters that do not depend on image quality for the evaluation of cardiac function during pregnancy.
The purpose of this study is to establish the reference range of TMAD parameters in Chinese Han singleton pregnancies in different pregnancy periods and early postpartum period and to explore the influencing factors of TMAD in singleton pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | – | Device: Ultrasound image acquisitionA total of 660 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 33 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 660 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 33 centers, with 20 cases in each center.
Key inclusion criteria (10 listed)
- Singleton pregnancy;
- Han nationality;
- 18-45 years old;
- Basal body mass index before pregnancy < 30 kg/m2;
- Normal blood pressure (139-90/89-60 mmHg);
Key exclusion criteria (5 listed)
- Multiple pregnancy;
- 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 |
|---|---|---|
| Ultrasound image acquisitionEchocardiography: left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement 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 (37-41 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 left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method
Time frame: From 11 weeks of gestation to 3-6 months postpartum
To establish the reference range of TMADmid and TMADmidpt% in Chinese Han singleton pregnancies using the TMAD method.
1 secondary outcome
Measurement of left ventricular systolic function using the Simpson's biplane method
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 15 Jul 2022.
- 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
33 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 33 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 10 inclusion and 5 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 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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 left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method (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 15 Jul 2022.