A Diagnostic Test Study of Characteristic Sound Waves in the Middle and Third Trimester of Pregnancy Women

NCT04861883 | Unknown

• 1 other identifier: SFUYIN-05
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Radial Artery

Keywords

pregnancy; diagnostic test; sound waves; radial artery

Outcome Measures

Primary Outcomes (4)

• Frequencies of characteristic sound waves in the pulses

  Using the Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands. The percentage(%) of frequencies of characteristic sound waves in the pulse will be calculated.

  The data will be collected,analyzed and calculated in about 7 days.

• The changes of sound waves in the pulses

  The changes of sound waves in the middle and third trimester of pregnancy women at different hertz(Hz) frequencies and SMPL amplitudes will be compared with relatively healthy women's.

  The discovery of characteristic sound waves may take 3 months.

• Diagnostic test

  The Percentage(%) of specificity, sensitivity, positive likelihood ratio and negative likelihood ratio of the "Pulse Detection System of Sound Waves" in the diagnosis of the middle and third trimester of pregnancy women.

  Diagnostic tests may take about 1 month.

• Sound waves analysis

  The Hertz(Hz) of the different segments of the sound waves in Wavelet transform; The Hertz(Hz) of the different layers of the sound waves in Hilbert-Huang; The SMPL amplitudes of sound waves in Discrete Fourier Transform； The sample Entropy(sampEn) of sound waves in Sample Entropy.

  1 month

Study Arms (2)

76 healthy the Middle and Third Trimester pregnant women in the trial group

The pulse sound waves of three parts and five layers of each of the two hands of 76 pregnant women will be collected by Pulse Detection System of Sound Waves.

76 relatively healthy non-pregnant women in the control group

The pulse sound waves of three parts and five layers of each of the two hands of 76 relatively healthy non-pregnant women will be collected by Pulse Detection System of Sound Waves.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The middle and third trimester Pregnant women and relatively healthy non-pregnant women

You may qualify if:

• Trial group:
• The pregnant women in the middle and third trimester of pregnancy diagnosed by laboratory and B-ultrasound；
• The first singleton pregnancy, from 13 weeks to parturition；
• There are no pregnancy complications, the vital signs are stable, and the biochemical examination is normal;
• Patients who have informed consent to accept this pulse collection.
• Control group:
• Those who are included in the relatively healthy population are those with negative diagnostic criteria for early pregnant women;
• Patients who have informed consent to accept this pulse collection;
• The vital signs are stable, the biochemical tests are normal, and there are no severe brain, liver and kidney diseases.

You may not qualify if:

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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (9)

• Cui H, Su J, Liang WW, Wang HL, Wang HF. Diagnostic analysis of abnormal increase of PASP in fetus in middle- and late-stage pregnancy by color Doppler echocardiography. Br J Radiol. 2020 Jun;93(1110):20191011. doi: 10.1259/bjr.20191011. Epub 2020 Mar 25.

  PMID: 32160003 BACKGROUND

• Rodriguez C, Chi YY, Chiu KH, Zhai X, Lingis M, Williams RS, Rhoton-Vlasak A, Nichols WW, Petersen JW, Segal MS, Conrad KP, Mohandas R. Wave reflections and global arterial compliance during normal human pregnancy. Physiol Rep. 2018 Dec;6(24):e13947. doi: 10.14814/phy2.13947.

  PMID: 30578623 BACKGROUND

• Li K, Zhang S, Chi Z, Yang Y, Jiang H, Yang L, Wang A, Zhang L, Chen F, Zheng D. Arterial Pulse Waveform Characteristics Difference between the Three Trimesters of Healthy Pregnant Women. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:5317-5320. doi: 10.1109/EMBC.2018.8513492.

  PMID: 30441537 BACKGROUND

• Li K, Zhang S, Yang L, Jiang H, Chi Z, Wang A, Yang Y, Li X, Hao D, Zhang L, Zheng D. Changes of Arterial Pulse Waveform Characteristics with Gestational Age during Normal Pregnancy. Sci Rep. 2018 Oct 22;8(1):15571. doi: 10.1038/s41598-018-33890-1.

  PMID: 30349022 BACKGROUND

• Martin JN Jr, Tucker JM. Missing or making the timely diagnosis of acute fatty liver of pregnancy (AFLP): lessons learned. J Matern Fetal Neonatal Med. 2022 Sep;35(18):3595-3601. doi: 10.1080/14767058.2020.1832075. Epub 2020 Oct 9.

  PMID: 33032483 BACKGROUND

• Rodger M, Sheppard D, Gandara E, Tinmouth A. Haematological problems in obstetrics. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):671-84. doi: 10.1016/j.bpobgyn.2015.02.004. Epub 2015 Mar 4.

  PMID: 25819750 BACKGROUND

• Lumbers ER, Pringle KG. Roles of the circulating renin-angiotensin-aldosterone system in human pregnancy. Am J Physiol Regul Integr Comp Physiol. 2014 Jan 15;306(2):R91-101. doi: 10.1152/ajpregu.00034.2013. Epub 2013 Oct 2.

  PMID: 24089380 BACKGROUND

• Bilton K, Hammer L, Zaslawski C. Contemporary Chinese pulse diagnosis: a modern interpretation of an ancient and traditional method. J Acupunct Meridian Stud. 2013 Oct;6(5):227-33. doi: 10.1016/j.jams.2013.04.002. Epub 2013 Apr 24.

  PMID: 24139459 BACKGROUND

• Drukker L, Droste R, Chatelain P, Noble JA, Papageorghiou AT. Safety Indices of Ultrasound: Adherence to Recommendations and Awareness During Routine Obstetric Ultrasound Scanning. Ultraschall Med. 2020 Apr;41(2):138-145. doi: 10.1055/a-1074-0722. Epub 2020 Feb 27.

  PMID: 32107757 BACKGROUND

Study Officials

• Lucheng Song, Doctor

  The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucheng Song, Doctor

CONTACT

+8613589089003; lucheng.s@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dean of orthopedic department

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: April 27, 2021
• Study Start: April 9, 2021
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CN (1)