Clinical trial NCT04717661: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
Official title: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Pregnancy
Radial Artery
Keywords: Early Pregnancy
Diagnostic Test
Radial Artery
Sound Waves
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-01-22
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: Early pregnancy women and relatively healthy non-pregnant women.

Brief summary: Pulse diagnosis is an important method to judge the status of patients in the process of diagnosis and treatment of traditional Chinese medicine. At present, the commonly used site of pulse diagnosis is the radial artery, which is divided into "cun""guan""chi". Whether the diagnosis of pregnancy can be diagnosed by pulse diagnosis has been perplexing clinicians. In long-term clinical practice, it is found that slippery pulse often occurs in the radial artery of pregnant women. Before the 13th week of pregnancy, it is called early pregnancy. During pregnancy, chorionic gonadotropin gradually increases, progesterone increases, humoral metabolism changes, blood volume increases, hemodilution and cardiac output increase. Other studies have shown that due to the effect of estrogen, the number of active levels of renin in plasma increase several times, and will increase with the progression of pregnancy. This series of changes in pregnant women may be reflected in the pulse. During the clinical pulse examination, our team has found that some pregnant women had no abnormality in pre-pregnancy examination such as B-ultrasound, and abnormal unsmooth pulse in the ulna could be felt during pulse examination. Through follow-up, it is found that this kind of pregnant women may have miscarriage or stillbirth.

Our team found that there are low-frequency sound waves in the radial artery, which carry the physiological and pathological information of the organs in the body, and developed a "Pulse Detection System of Sound Waves". Previous projects have explored the abnormal sound waves of radial artery in patients with sequelae of cerebral infarction, stable coronary heart disease, chronic gastritis, neck-shoulder syndrome, liver cirrhosis and other diseases and achieved certain results.

Therefore, in this study, the "Pulse Detection System of Sound Waves" will be used to collect the sound waves in the radial artery of 76 healthy early pregnant women and 76 relatively healthy non-pregnant women. Fourier transform, wavelet analysis, Hilbert yellow transform and other methods will be used to identify the different characteristics of the pulse acoustic signals, and observe the time-frequency domain characteristics of the trial group and the control group.And researchers will carry on the diagnostic test, calculate the sensitivity and specificity of the "Pulse Detection System of Sound Waves" in the diagnosis of pregnancy. 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.


Eligibility criteria: Inclusion Criteria:

Trial group:

1. Pregnant women who have been diagnosed as early pregnancy by laboratory and ultrasound;
2. First-born singleton pregnancy, from 6 weeks to 13 weeks;
3. There are no pregnancy complications, the vital signs were stable, and the results of biochemical tests were normal;
4. Patients with informed consent to accept this pulse collection.

Control group:

1. The inclusion of relatively healthy women is those with negative diagnostic criteria for early pregnancy pregnant women;
2. Patients with informed consent to accept this pulse collection;
3. The vital signs were stable, the results of biochemical tests were normal, and there were no severe diseases of brain, liver and kidney.

Exclusion Criteria:

Trial group:

1. Pregnant women with ovarian, fallopian tube, uterine diseases, hypertension and diabetes during pregnancy;
2. Definitely diagnose 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; history of miscarriage；
4. Those who have a severe illness and sit for less than 10 minutes in a quiet state;
5. Patients with mental illness, depression, and cognitive impairment;
6. Pulse on back of wrist, oblique-running pulse, etc. who are not easy to collect 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. Pulse on back of wrist, oblique-running pulse, etc. who are not easy to collect 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 three 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: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
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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