A Diagnostic Test Study of Characteristic Sound Waves in the Middle and Third Trimester of Pregnancy Women
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Lucheng Song, Doctor
- Phone Number: +8613589089003
- Email: lucheng.s@163.com
Study Locations
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Shandong
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Jinan, Shandong, China, 250014
- Recruiting
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
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Principal Investigator:
- Lucheng Song, PH.D
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Sub-Investigator:
- Yameng Zhang, PH.D
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Sub-Investigator:
- Shanmei Sun, PH.D
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Contact:
- Lili Cao, PH.D
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Sub-Investigator:
- Wei Guo, PH.D
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Sub-Investigator:
- Tongtong Xu
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Sub-Investigator:
- Tao Ma
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Sub-Investigator:
- Honglin Li
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Principal Investigator:
- Mengyao Li
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Sub-Investigator:
- Jiamin Gao
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- Menstrual women.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frequencies of characteristic sound waves in the pulses
Time Frame: The data will be collected,analyzed and calculated in about 7 days.
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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.
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The data will be collected,analyzed and calculated in about 7 days.
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The changes of sound waves in the pulses
Time Frame: The discovery of characteristic sound waves may take 3 months.
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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.
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The discovery of characteristic sound waves may take 3 months.
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Diagnostic test
Time Frame: Diagnostic tests may take about 1 month.
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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.
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Diagnostic tests may take about 1 month.
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Sound waves analysis
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Lucheng Song, Doctor, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- SFUYIN-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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