PregnancyNCT04861883
A Diagnostic Test Study of Characteristic Sound Waves in the Middle and Third Trimester of Pregnancy Women
An observational study of Pregnancy and Radial Artery, run by Qianfoshan Hospital at 1 site in China.
Trial 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. 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
- Pregnancy, Radial Artery
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2021to 9 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: The middle and third trimester Pregnant women and relatively healthy non-pregnant women
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Lili Cao, PH.D
Lucheng Song, PH.D
About this study
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.
Read the detailed description
Pregnancy is a special physiological stage for women, and the changes of Qi and blood in the body can be reflected in time by the dynamic changes of pulse, which provides an important basis for clinical diagnosis and treatment. Pregnancy is a very complex and coordinated physiological process, in which the physiological changes related to pulse changes include: 1. Changes in blood pressure. Relatively speaking, in the middle trimester, the blood pressure is low; at the end of the pregnancy, the blood pressure increases slightly, the general systolic blood pressure does not change, the diastolic blood pressure decreases slightly due to peripheral vasodilation, hemodilution and placental arteriovenous short circuit, and the pulse pressure increases slightly. 2.The change of cardiac output. Cardiac output increases gradually from 8-10 weeks of gestation and reaches the peak at 32-34 weeks of pregnancy until delivery. 3.The change of blood volume. The maternal blood volume begins to increase from 6-8 weeks of pregnancy and reaches the peak at 32-34 weeks of pregnancy until delivery. The above physiological changes are closely related to the physiological function of Zang-fu organs, which leads to the change of slippery pulse. With the continuous development of modern pulsology, Professor Lucheng Song has been studying the knowledge of modern physics such as hemodynamics, hydrodynamics and acoustics based on his long-term clinical practice. By touching different levels of depth and the part of 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 produces 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.Different pulse sound waves were collected by using Pulse Detection System of Sound Waves(PDSSW),and ideal results were obtained through analysis. 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.Based on the above analysis, this study will use PDSSW to collect the pulse waves of 76 the Middle and Third Trimester of Pregnancy and 76 relatively healthy women.Fourier transform, wavelet analysis, Hilbert-Huang transform and other methods will be used to identify the different characteristics of the sound wave signals, and observe the time-frequency domain characteristics of the trial group and the control group. Then diagnostic tests will be performed to calculate the sensitivity and specificity of PDSSW in the diagnosis of the middle and third trimester of pregnancy women.This trial will further verify the effectiveness of pulse diagnosis and lay a foundation for the diagnosis of complication of pregnancy by pulse diagnosis instruments.
- Conditions
- Pregnancy, Radial Artery
- Keywords
- pregnancy, diagnostic test, sound waves, radial artery
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 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. |
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 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.
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 middle and third trimester of pregnancy 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 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.
Measured: 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.
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 posted27 Apr 2021
- Study start9 Apr 2021
- Primary completion9 Mar 2022 (estimated)
- Study completion9 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- NCT04861883
- Sponsor's protocol ID
- SFUYIN-05
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32160003Rodriguez 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.
PubMed 30578623Li 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 30441537Li 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 30349022Martin 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.
PubMed 33032483Rodger 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 25819750Lumbers 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 24089380Bilton 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 24139459Drukker 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 32107757
Study at a glance
From the registry record, last updated by the sponsor on 27 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 the Middle and Third Trimester of Pregnancy Women
- ClinicalTrials.gov ID
- NCT04861883
- Acronym / sponsor ID
- SFUYIN-05
- Conditions
- Pregnancy, Radial Artery
- Keywords
- pregnancy, diagnostic test, sound waves, radial artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 9 Mar 2022 (estimated)
- Study completion
- 9 Mar 2022 (estimated)
- First posted
- 27 Apr 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.
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.
Detailed description
Pregnancy is a special physiological stage for women, and the changes of Qi and blood in the body can be reflected in time by the dynamic changes of pulse, which provides an important basis for clinical diagnosis and treatment. Pregnancy is a very complex and coordinated physiological process, in which the physiological changes related to pulse changes include: 1. Changes in blood pressure. Relatively speaking, in the middle trimester, the blood pressure is low; at the end of the pregnancy, the blood pressure increases slightly, the general systolic blood pressure does not change, the diastolic blood pressure decreases slightly due to peripheral vasodilation, hemodilution and placental arteriovenous short circuit, and the pulse pressure increases slightly. 2.The change of cardiac output. Cardiac output increases gradually from 8-10 weeks of gestation and reaches the peak at 32-34 weeks of pregnancy until delivery. 3.The change of blood volume. The maternal blood volume begins to increase from 6-8 weeks of pregnancy and reaches the peak at 32-34 weeks of pregnancy until delivery. The above physiological changes are closely related to the physiological function of Zang-fu organs, which leads to the change of slippery pulse. With the continuous development of modern pulsology, Professor Lucheng Song has been studying the knowledge of modern physics such as hemodynamics, hydrodynamics and acoustics based on his long-term clinical practice. By touching different levels of depth and the part of 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 produces 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.Different pulse sound waves were collected by using Pulse Detection System of Sound Waves(PDSSW),and ideal results were obtained through analysis. 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.Based on the above analysis, this study will use PDSSW to collect the pulse waves of 76 the Middle and Third Trimester of Pregnancy and 76 relatively healthy women.Fourier transform, wavelet analysis, Hilbert-Huang transform and other methods will be used to identify the different characteristics of the sound wave signals, and observe the time-frequency domain characteristics of the trial group and the control group. Then diagnostic tests will be performed to calculate the sensitivity and specificity of PDSSW in the diagnosis of the middle and third trimester of pregnancy women.This trial will further verify the effectiveness of pulse diagnosis and lay a foundation for the diagnosis of complication of pregnancy by pulse diagnosis instruments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The middle and third trimester Pregnant women and relatively healthy non-pregnant women
Key inclusion criteria (9 listed)
- 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.
- Those who are included in the relatively healthy population are those with negative diagnostic criteria for early pregnant women;
Key exclusion criteria (16 listed)
- 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;
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 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 changes of sound waves in the pulses
Time frame: The discovery of characteristic sound waves may take 3 months.
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.
Diagnostic test
Time frame: Diagnostic tests may take about 1 month.
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.
Sound waves analysis
Time frame: 1 month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 32160003Cui 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.
- Background: PubMed 30578623Rodriguez 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.
- 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.
- 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 33032483Martin 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.
- 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 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 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 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.
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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 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 27 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 NCT04861883, which also lists 9 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 27 Apr 2021.