Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies
1 other identifier
observational
660
1 country
33
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
33 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 15, 2022
July 1, 2022
12 months
April 29, 2022
July 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
From 11 weeks of gestation to 3-6 months postpartum
Study Arms (1)
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.
Interventions
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).
Eligibility Criteria
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.
You may qualify if:
- Singleton pregnancy;
- Han nationality;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Chongqing Fifth People's Hospital
Chongqing, Chongqing Municipality, 400000, China
Chongqing Banan District People's Hospital
Chongqing, Chongqing Municipality, 401320, China
Chongqing Qianjiang District Central Hospital
Chongqing, Chongqing Municipality, 409000, China
Maternity and Child Care Centers of Fujian Province
Fuzhou, Fujian, 350001, China
Hainan Women and Children's Medical Center
Haikou, Hainan, 570312, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002, China
Nanyang First People's Hospital
Nanyang, Henan, 473000, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
The Center Hospital of Wuhan
Wuhan, Hubei, 430014, China
Maternal and Child Health Care Hospital Hubei
Wuhan, Hubei, 430070, China
Jilin Provincial Women and Children Health Hospital
Changchun, Jilin, 130012, China
Jilin People's Hospital
Jilin, Jilin, 132001, China
Jilin Central General Hospital
Jilin, Jilin, 132011, China
Siping Women and Infants Hospital
Siping, Jilin, 136000, China
Yanji Maternal and Infant Hospital
Yanji, Jilin, 133001, China
Dalian Friendship Hospital
Dalian, Liaoning, 116001, China
Dalian Municipal Women and Children's Medical Center
Dalian, Liaoning, 116033, China
Women And Children's Hospital of Jinzhou
Jinzhou, Liaoning, 121000, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Shenyang Maternity And Child Health Hospital
Shenyang, Liaoning, 110000, China
the First Hospital of China Medical Univeristy
Shenyang, Liaoning, 110000, China
Tieling Women's And Children's Hospital
Tieling, Liaoning, 112000, China
Ningxia Maternal And Child Health Care Hospital
Yinchuan, Ningxia, 750000, China
Qinghai Provincial Maternal and Child Health Hospital
Xining, Qinghai, 810000, China
ShaanXi Province People's Hospital
Xi'an, Shaanxi, 710068, China
Heze Municipal Hospital
Heze, Shandong, 274000, China
Shandong Maternal and Child Health Hospital
Jinan, Shandong, 250014, China
Weifang Maternal and Child Health Hospital
Weifang, Shandong, 261011, China
ZiBo Central Hospital
Zibo, Shandong, 255020, China
Panzhihua Maternal and Child Hospital
Panzhihua, Sichuan, 623000, China
Yaan People's Hospital
Ya'an, Sichuan, 625000, China
Yunnan Maternal And Child Health Care Hospital
Kunming, Yunnan, 650051, China
Study Officials
- PRINCIPAL INVESTIGATOR
Chunyan Ma, MD
First Hospital of China Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Cardiovascular Ultrasound
Study Record Dates
First Submitted
April 29, 2022
First Posted
May 16, 2022
Study Start
July 1, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2024
Last Updated
July 15, 2022
Record last verified: 2022-07