Viewing Study NCT04717661


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Study NCT ID: NCT04717661
Status: UNKNOWN
Last Update Posted: 2021-04-30
First Post: 2021-01-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
Sponsor: Qianfoshan Hospital
Organization:

Study Overview

Official Title: A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
Status: UNKNOWN
Status Verified Date: 2021-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: