Clinical trial NCT05375123: Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies
Official title: Reference Range for Tissue Motion Tracking of Mitral Annulus Displacement in Chinese Han Singleton Pregnancies: a Prospective, Multicenter, Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy
Left Ventricular Systolic Function
Tissue Motion Tracking of Mitral Annular Displacement
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 660
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;
* 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:

* 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.

Primary outcomes:
measure: Measurement of left ventricular systolic function in Chinese Han singleton pregnancies using the TMAD method
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Secondary outcomes:
measure: Measurement of left ventricular systolic function using the Simpson's biplane method
timeFrame: From 11 weeks of gestation to 3-6 months postpartum
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Fifth People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Banan District People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Qianjiang District Central Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Maternity and Child Care Centers of Fujian Province
state: Fujian
city: Haikou
country: China
facility: Hainan Women and Children's Medical Center
state: Hainan
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: The Center Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Maternal and Child Health Care Hospital Hubei
state: Hubei
city: Changchun
country: China
facility: Jilin Provincial Women and Children Health Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin People's Hospital
state: Jilin
city: Jilin
country: China
facility: Jilin Central General Hospital
state: Jilin
city: Siping
country: China
facility: Siping Women and Infants Hospital
state: Jilin
city: Yanji
country: China
facility: Yanji Maternal and Infant Hospital
state: Jilin
city: Dalian
country: China
facility: Dalian Friendship Hospital
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Women and Children's Medical Center
state: Liaoning
city: Jinzhou
country: China
facility: Women And Children's Hospital of Jinzhou
state: Liaoning
city: Jinzhou
country: China
facility: The First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Maternity And Child Health Hospital
state: Liaoning
city: Shenyang
country: China
facility: the First Hospital of China Medical Univeristy
state: Liaoning
city: Tieling
country: China
facility: Tieling Women's And Children's Hospital
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Maternal And Child Health Care Hospital
state: Ningxia
city: Xining
country: China
facility: Qinghai Provincial Maternal and Child Health Hospital
state: Qinghai
city: Xi'an
country: China
facility: ShaanXi Province People's Hospital
state: Shaanxi
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Maternal and Child Health Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Maternal and Child Health Hospital
state: Shandong
city: Zibo
country: China
facility: ZiBo Central Hospital
state: Shandong
city: Panzhihua
country: China
facility: Panzhihua Maternal and Child Hospital
state: Sichuan
city: Ya'an
country: China
facility: Yaan People's Hospital
state: Sichuan
city: Kunming
country: China
facility: Yunnan Maternal And Child Health Care Hospital
state: Yunnan
Study officials:
affiliation: First Hospital of China Medical University
name: Chunyan Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: