Clinical trial NCT04861883: A Diagnostic Test Study of Characteristic Sound Waves in the Middle and Third Trimester of Pregnancy Women
Official title: A Diagnostic Test Study of Characteristic Sound Waves in the Middle and Third Trimester of Pregnancy Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Radial Artery
Keywords: pregnancy
diagnostic test
sound waves
radial artery
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 152
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The middle and third trimester Pregnant women and relatively healthy non-pregnant women

Brief summary: Pregnancy is a very complex and coordinated physiological process.The physiological changes are closely related to the physiological function of Zang-fu organs, which leads to the change of slippery pulse. By touching different levels of depth and the part of the radial artery, it is found that the formation mechanism of pulse information, especially unsmooth pulse, is similar to the principle of sonar emission and reception: the heart is equivalent to the transmitting device of sonar wave. Each contraction of the heart produces a cluster of powerful sound waves, which are rapidly transmitted to the whole body along the arterial wall and the blood in it as a medium. More than 90% of the arterial blood flow of normal organs and tissues is a steady laminar flow, which does not produce turbulence, so there is abnormal vibration when a certain organ and tissue has pathological changes. The arterial blood flow is squeezed and deformed which causing turbulence and abnormal vibrations, which are fused with a larger cluster of sound waves transmitted by the heart and then transmitted to the whole body. The investigators can feel this kind of sound waves which combine abnormal vibration waves by touching different levels of arteries close to the body surface, including the radial artery. At the same time, Professor Lucheng Song's team has conducted in-depth research on the characteristic unsmooth pulse of stable coronary heart disease, liver cirrhosis, gastritis and other diseases.During pregnancy, due to the significant increase in blood flow and maternal changes , the shape of sound waves transmitted to the radial artery in the artery will be changed. Professor Lucheng Song found in clinical practice that the pregnant pulse will have different sensations of smoothness and penetration in different parts of the finger, by touching different levels of depth and the part of the radial artery. It was found that the pulse condition of normal pregnant women in the middle and third trimester of pregnancy was different from that of normal non-pregnant women in different level and part of radial artery.This study will verify the efficacy of pulse diagnosis of traditional Chinese medicine in the diagnosis of pregnancy and lay a foundation for the diagnosis of abnormal pregnancy.

Detailed description: Pregnancy is a special physiological stage for women, and the changes of Qi and blood in the body can be reflected in time by the dynamic changes of pulse, which provides an important basis for clinical diagnosis and treatment. Pregnancy is a very complex and coordinated physiological process, in which the physiological changes related to pulse changes include: 1. Changes in blood pressure. Relatively speaking, in the middle trimester, the blood pressure is low; at the end of the pregnancy, the blood pressure increases slightly, the general systolic blood pressure does not change, the diastolic blood pressure decreases slightly due to peripheral vasodilation, hemodilution and placental arteriovenous short circuit, and the pulse pressure increases slightly. 2.The change of cardiac output. Cardiac output increases gradually from 8-10 weeks of gestation and reaches the peak at 32-34 weeks of pregnancy until delivery. 3.The change of blood volume. The maternal blood volume begins to increase from 6-8 weeks of pregnancy and reaches the peak at 32-34 weeks of pregnancy until delivery. The above physiological changes are closely related to the physiological function of Zang-fu organs, which leads to the change of slippery pulse. With the continuous development of modern pulsology, Professor Lucheng Song has been studying the knowledge of modern physics such as hemodynamics, hydrodynamics and acoustics based on his long-term clinical practice. By touching different levels of depth and the part of radial artery, it is found that the formation mechanism of pulse information, especially unsmooth pulse, is similar to the principle of sonar emission and reception: the heart is equivalent to the transmitting device of sonar wave. Each contraction of the heart produces a cluster of powerful sound waves, which are rapidly transmitted to the whole body along the arterial wall and the blood in it as a medium.More than 90% of the arterial blood flow of normal organs and tissues is a steady laminar flow, which does not produce turbulence, so there is abnormal vibration when a certain organ and tissue has pathological changes. The arterial blood flow is squeezed and deformed which causing turbulence and produces abnormal vibrations, which are fused with a larger cluster of sound waves transmitted by the heart and then transmitted to the whole body. The investigators can feel this kind of sound waves which combine abnormal vibration waves by touching different levels of arteries close to the body surface, including the radial artery. At the same time, Professor Lucheng Song's team has conducted in-depth research on the characteristic unsmooth pulse of stable coronary heart disease, liver cirrhosis, gastritis and other diseases.Different pulse sound waves were collected by using Pulse Detection System of Sound Waves(PDSSW),and ideal results were obtained through analysis. During pregnancy, due to the significant increase in blood flow and maternal changes,the shape of sound waves transmitted to the radial artery in the artery will be changed. Professor Lucheng Song found in clinical practice that the pregnant pulse will have different sensations of smoothness and penetration in different parts of the finger, by touching different levels of depth and the part of the radial artery. It was found that the pulse condition of normal pregnant women in the middle and third trimester of pregnancy was different from that of normal non-pregnant women in different level and part of radial artery.Based on the above analysis, this study will use PDSSW to collect the pulse waves of 76 the Middle and Third Trimester of Pregnancy and 76 relatively healthy women.Fourier transform, wavelet analysis, Hilbert-Huang transform and other methods will be used to identify the different characteristics of the sound wave signals, and observe the time-frequency domain characteristics of the trial group and the control group. Then diagnostic tests will be performed to calculate the sensitivity and specificity of PDSSW in the diagnosis of the middle and third trimester of pregnancy women.This trial will further verify the effectiveness of pulse diagnosis and lay a foundation for the diagnosis of complication of pregnancy by pulse diagnosis instruments.

Eligibility criteria: Inclusion Criteria:

Trial group:

1. The pregnant women in the middle and third trimester of pregnancy diagnosed by laboratory and B-ultrasound；
2. The first singleton pregnancy, from 13 weeks to parturition；
3. There are no pregnancy complications, the vital signs are stable, and the biochemical examination is normal;
4. Patients who have informed consent to accept this pulse collection.

Control group:

1. Those who are included in the relatively healthy population are those with negative diagnostic criteria for early pregnant women;
2. Patients who have informed consent to accept this pulse collection;
3. The vital signs are stable, the biochemical tests are normal, and there are no severe brain, liver and kidney diseases.

Exclusion Criteria:

Trial group:

1. Pregnant women with ovarian, fallopian tube, uterine diseases, hypertension and diabetes during pregnancy;
2. Definitely diagnosed patients with respiratory, cardiovascular, cerebrovascular, liver and kidney, blood, endocrine and other system diseases and severe infectious diseases;
3. Those who have had a cesarean section or history of miscarriage;
4. Those who have a serious illness and sit for less than 10 minutes in a quiet state;
5. Patients with mental illness, depression, and cognitive impairment;
6. Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
7. Those who have incomplete information due to subjective or objective reasons that affect the result judgment;
8. Patients with Parkinson's or other limb tremors.

Control group:

1. Those who have had a history of miscarriage or ectopic pregnancy;
2. Patients with severe infectious diseases;
3. Those who are not easy to collect pulse manifestation such as pulse on back of wrist and oblique-running pulse;
4. The incomplete information affects the judgment of the result due to subjective or objective reasons;
5. Patients with Parkinson's or other limb tremors;
6. Menstrual women.

Primary outcomes:
measure: Frequencies of characteristic sound waves in the pulses
timeFrame: The data will be collected,analyzed and calculated in about 7 days.
measure: The changes of sound waves in the pulses
timeFrame: The discovery of characteristic sound waves may take 3 months.
measure: Diagnostic test
timeFrame: Diagnostic tests may take about 1 month.
measure: Sound waves analysis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
name: Lucheng Song, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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