Early PregnancyNCT04717661
A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
An observational study of Early Pregnancy and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
Trial 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". Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy, Radial Artery
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Early pregnancy women and relatively healthy non-pregnant women.
Who may be able to join
- Trial group:
- Pregnant women who have been diagnosed as early pregnancy by laboratory and ultrasound;
- First-born singleton pregnancy, from 6 weeks to 13 weeks;
- There are no pregnancy complications, the vital signs were stable, and the results of biochemical tests were normal;
- Patients with informed consent to accept this pulse collection.
- Control group:
Show all 9Show fewer
- The inclusion of relatively healthy women is those with negative diagnostic criteria for early pregnancy pregnant women;
- Patients with informed consent to accept this pulse collection;
- The vital signs were stable, the results of biochemical tests were normal, and there were no severe diseases of brain, liver and kidney.
Who cannot join
- Trial group:
- Pregnant women with ovarian, fallopian tube, uterine diseases, hypertension and diabetes during pregnancy;
- Definitely diagnose 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; history of miscarriage；
- Those who have a severe illness and sit for less than 10 minutes in a quiet state;
- Patients with mental illness, depression, and cognitive impairment;
Show all 16Show fewer
- Pulse on back of wrist, oblique-running pulse, etc. who are not easy to collect 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;
- Pulse on back of wrist, oblique-running pulse, etc. who are not easy to collect 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Jinan, Shandong, 250000
Lili Cao, PH.D, qykyc309@163.com
Lucheng Song, PH.D
About this study
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.
- Conditions
- Early Pregnancy, Radial Artery
- Keywords
- Early Pregnancy, Diagnostic Test, Radial Artery, Sound Waves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 76 healthy early 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of characteristic sound waves in the pulses
Using Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands.The percentage(%) of frequencies of characteristics sound waves in the pulse will be calculated.
Measured: 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 early pregnant women at different hertz(Hz) frequencies and SMPL amplitudes will be compared with relatively healthy women's.
Measured: The discovery of characteristic sound waves may take three months.
Diagnostic test
The percentage(%) of sensitivity,specificity positive likelihood ratio and negative likelihood ratio of the ''Pulse Detection System of Sound Waves'' in the diagnosis of early pregnant women.
Measured: Diagnostic tests may take about 1 month.
Sound waves analysis
The Hertz(Hz) of the different segments of 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.
time-frequency characteristics, time-domain characteristics and frequency-domain features will be extracted.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Early PregnancyStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Lucheng Song, Doctor, Principal investigator, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717661
- Sponsor's protocol ID
- SFUYIN-01
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carusi D. Pregnancy of unknown location: Evaluation and management. Semin Perinatol. 2019 Mar;43(2):95-100. doi: 10.1053/j.semperi.2018.12.006. Epub 2018 Dec 20.
PubMed 30606496Drukker 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.
PubMed 32107757Bilton 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.
PubMed 24139459Lumbers 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.
PubMed 24089380Tkachenko O, Shchekochikhin D, Schrier RW. Hormones and hemodynamics in pregnancy. Int J Endocrinol Metab. 2014 Apr 1;12(2):e14098. doi: 10.5812/ijem.14098. eCollection 2014 Apr.
PubMed 24803942Rodger 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.
PubMed 25819750Li 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.
PubMed 30349022Li 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.
PubMed 30441537
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test Study of Characteristic Sound Waves in Radial Artery of Early Pregnant Women
- ClinicalTrials.gov ID
- NCT04717661
- Acronym / sponsor ID
- SFUYIN-01
- Conditions
- Early Pregnancy, Radial Artery
- Keywords
- Early Pregnancy, Diagnostic Test, Radial Artery, Sound Waves
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 76 healthy early 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Early pregnancy women and relatively healthy non-pregnant women.
Key inclusion criteria (9 listed)
- Pregnant women who have been diagnosed as early pregnancy by laboratory and ultrasound;
- First-born singleton pregnancy, from 6 weeks to 13 weeks;
- There are no pregnancy complications, the vital signs were stable, and the results of biochemical tests were normal;
- Patients with informed consent to accept this pulse collection.
- The inclusion of relatively healthy women is those with negative diagnostic criteria for early pregnancy pregnant women;
Key exclusion criteria (16 listed)
- Pregnant women with ovarian, fallopian tube, uterine diseases, hypertension and diabetes during pregnancy;
- Definitely diagnose 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; history of miscarriage；
- Those who have a severe illness and sit for less than 10 minutes in a quiet state;
- Patients with mental illness, depression, and cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequencies of characteristic sound waves in the pulses
Time frame: The data will be collected,analyzed and calculated in about 7 days.
Using Pulse Detection System of Sound Waves (PDSSW) to collect the pulse waves of both hands.The percentage(%) of frequencies of characteristics sound waves in the pulse will be calculated.
The changes of sound waves in the pulses
Time frame: The discovery of characteristic sound waves may take three months.
The changes of sound waves in the early pregnant women at different hertz(Hz) frequencies and SMPL amplitudes will be compared with relatively healthy women's.
Diagnostic test
Time frame: Diagnostic tests may take about 1 month.
The percentage(%) of sensitivity,specificity positive likelihood ratio and negative likelihood ratio of the ''Pulse Detection System of Sound Waves'' in the diagnosis of early pregnant women.
Sound waves analysis
Time frame: 1 month
The Hertz(Hz) of the different segments of 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. time-frequency characteristics, time-domain characteristics and frequency-domain features will be extracted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 30606496Carusi D. Pregnancy of unknown location: Evaluation and management. Semin Perinatol. 2019 Mar;43(2):95-100. doi: 10.1053/j.semperi.2018.12.006. Epub 2018 Dec 20.
- Background: PubMed 32107757Drukker 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.
- Background: PubMed 24139459Bilton 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.
- Background: PubMed 24089380Lumbers 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.
- Background: PubMed 24803942Tkachenko O, Shchekochikhin D, Schrier RW. Hormones and hemodynamics in pregnancy. Int J Endocrinol Metab. 2014 Apr 1;12(2):e14098. doi: 10.5812/ijem.14098. eCollection 2014 Apr.
- Background: PubMed 25819750Rodger 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.
- Background: PubMed 30349022Li 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.
- Background: PubMed 30441537Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucheng Song, Doctor principal investigator
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucheng Song, Doctor (+8613589089003, lucheng.s@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of characteristic sound waves in the pulses (time frame: The data will be collected,analyzed and calculated in about 7 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04717661, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.