Pulse WaveNCT05428878
Pulse and Constitution of Pregnant Women
An observational study of Pulse Wave and Pregnancy, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The present project plans to detect pregnant pulses using this portable ANS (autonomic nervous system) Watch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pulse Wave, Pregnancy
- What is being tested?
- ANS Watch
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2022to 20 Oct 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females aged 20-45 years with a pregnant condition or a non-pregnant condition.
Who may be able to join
- nonpregnant females and singleton pregnant females aged 20 - 45 years;
- no estrogen, progesterone, or ovulation inducing medications were in the past six months
Who cannot join
- active heart disease, liver disease, kidney disease, or thyroid disease;
- any chronic disease which needs medication
- smoking, drug abuse, or alcohol abuse;
- psychiatric disorders or impaired cognitive function;
- taking Chinese medicine or western medicine in three months;
- Acute conditions currently, such as gastroenteritis, upper airway infection, acute attach of asthma, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shan-Yu Su
Taichung, 404
Shan-Yu Su Su, M.D., +886-920125943 ext. 4561, shanyusu@gmail.com
About this study
Official title: Prediction of Pregnancy Constitutions and Pregnancy Slippery Pulse Using ANSWatch
The present project plans to detect pregnant pulses using this portable ANS (autonomic nervous system) Watch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited.
Read the detailed description
ANS(autonomic nervous system) Watch has been developed as to detect pulse waves using a pressure detector. It is used to measured cardiovascular indices, including cardiac output, and vessel stiffness. ANSWatch is developed to apply to the prediction of traditional Chinese medicine (TCM) pulses, such as the wiry pulse. There are 28 types of pulses in TCM. Among them, the slippery pulse is the most commonly seen pulse in pregnant women. The present project plans to detect pregnant pulses using this portable ANSWatch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited. After taking the indices of the subjects, a neural network is designed to provide the prediction for pregnancy constitution, pregnancy pulse and slippery pulse in pregnant women.
- Conditions
- Pulse Wave, Pregnancy
- Being tested
- ANS Watch
- Keywords
- pregnant women, pulse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS WatchDiagnostic test
Also called Constitution questionnaire
- ANS Watch will be used to record the pulse waves
- Constitution questionnaire will be used to measure the constitution type
| Study group | Role | What they receive |
|---|---|---|
| Pregnant | pregnant women Receives: Diagnostic Test: ANS Watch | |
| Non-pregnant | non-pregnant women Receives: Diagnostic Test: ANS Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse waves
The indices of pulse waves measured by ANSWatch , a pulse wave machine(https://www.taiwanscientific.com.tw/%E5%BF%83%E5%BE%8B%E5%A4%A7%E5%B8%ABanswatch).
A neural network is designed to provide the prediction for pregnancy pulse.
Measured: Day 1
Secondary outcomes (1)
Constitution
Nine constitutions will be measured using the "Nine constitution Questionnaire" (in Chinese). This questionnaire defines whether subjects have Yin-deficiency, Yang-deficiency, Qi-deficiency, Phlegm-dampness, Dampness-heat, Special dialesis, Blood-stasis, Qi-depression, and Neuter constitutions.
The questionnaire is divided into several sections, each addressing different aspects of the subject's constitution. Within each section, there are 6 to 8 sub-questions, and responses are rated on a scale from 1 to 5, reflecting the intensity or frequency of the subject's experiences.Sum the scores from all sub-questions within the section to obtain the raw score,which is then transformed to a 0-100 scale.
If the transformed score falls below 30, it suggests that the subject does not exhibit characteristics of this constitution.Scores between 30 and 40 indicate a tendency towards this constitution.Scores exceeding 40 indicate that the subject belongs to this constitution.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start11 Apr 2022
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulse WaveStudies of the same condition, open and under way.
- More trials run by China Medical University 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan-Yu Su, M.D., Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428878
- Sponsor's protocol ID
- CMUH110-REC2-144
- Status last verified
- May 2024
- First submitted
- 13 Jun 2022
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plans to make individual participant data (IPD) available to other researchers.
Publications
Sanghavi M, Rutherford JD. Cardiovascular physiology of pregnancy. Circulation. 2014 Sep 16;130(12):1003-8. doi: 10.1161/CIRCULATIONAHA.114.009029. No abstract available.
PubMed 25223771Zhang YL, Zheng YY, Ma ZC, Sun YN. Radial pulse transit time is an index of arterial stiffness. Hypertens Res. 2011 Jul;34(7):884-7. doi: 10.1038/hr.2011.41. Epub 2011 May 19.
PubMed 21593741Pollonini L, Padhye NS, Re R, Torricelli A, Simpson RJ, Dacso CC. Pulse transit time measured by photoplethysmography improves the accuracy of heart rate as a surrogate measure of cardiac output, stroke volume and oxygen uptake in response to graded exercise. Physiol Meas. 2015 May;36(5):911-24. doi: 10.1088/0967-3334/36/5/911. Epub 2015 Apr 9.
PubMed 25856085Khalil SF, Mohktar MS, Ibrahim F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors (Basel). 2014 Jun 19;14(6):10895-928. doi: 10.3390/s140610895.
PubMed 24949644
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pregnancy Constitutions and Pregnancy Slippery Pulse Using ANSWatch
- ClinicalTrials.gov ID
- NCT05428878
- Acronym / sponsor ID
- CMUH110-REC2-144
- Conditions
- Pulse Wave, Pregnancy
- Keywords
- pregnant women, pulse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 23 Jun 2022 (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.
The present project plans to detect pregnant pulses using this portable ANS (autonomic nervous system) Watch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited.
Detailed description
ANS(autonomic nervous system) Watch has been developed as to detect pulse waves using a pressure detector. It is used to measured cardiovascular indices, including cardiac output, and vessel stiffness. ANSWatch is developed to apply to the prediction of traditional Chinese medicine (TCM) pulses, such as the wiry pulse. There are 28 types of pulses in TCM. Among them, the slippery pulse is the most commonly seen pulse in pregnant women. The present project plans to detect pregnant pulses using this portable ANSWatch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited. After taking the indices of the subjects, a neural network is designed to provide the prediction for pregnancy constitution, pregnancy pulse and slippery pulse in pregnant women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant | – | Diagnostic Test: ANS Watchpregnant women |
| Non-pregnant | – | Diagnostic Test: ANS Watchnon-pregnant women |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females aged 20-45 years with a pregnant condition or a non-pregnant condition.
Key inclusion criteria (2 listed)
- nonpregnant females and singleton pregnant females aged 20 - 45 years;
- no estrogen, progesterone, or ovulation inducing medications were in the past six months
Key exclusion criteria (6 listed)
- active heart disease, liver disease, kidney disease, or thyroid disease;
- any chronic disease which needs medication
- smoking, drug abuse, or alcohol abuse;
- psychiatric disorders or impaired cognitive function;
- taking Chinese medicine or western medicine in three months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS WatchAlso: Constitution questionnaire1. ANS Watch will be used to record the pulse waves 2. Constitution questionnaire will be used to measure the constitution type | Diagnostic test | Non-pregnant, Pregnant |
Primary outcome
Pulse waves
Time frame: Day 1
The indices of pulse waves measured by ANSWatch , a pulse wave machine(https://www.taiwanscientific.com.tw/%E5%BF%83%E5%BE%8B%E5%A4%A7%E5%B8%ABanswatch). A neural network is designed to provide the prediction for pregnancy pulse.
1 secondary outcome
Constitution
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 25223771Sanghavi M, Rutherford JD. Cardiovascular physiology of pregnancy. Circulation. 2014 Sep 16;130(12):1003-8. doi: 10.1161/CIRCULATIONAHA.114.009029. No abstract available.
- Background: PubMed 21593741Zhang YL, Zheng YY, Ma ZC, Sun YN. Radial pulse transit time is an index of arterial stiffness. Hypertens Res. 2011 Jul;34(7):884-7. doi: 10.1038/hr.2011.41. Epub 2011 May 19.
- Background: PubMed 25856085Pollonini L, Padhye NS, Re R, Torricelli A, Simpson RJ, Dacso CC. Pulse transit time measured by photoplethysmography improves the accuracy of heart rate as a surrogate measure of cardiac output, stroke volume and oxygen uptake in response to graded exercise. Physiol Meas. 2015 May;36(5):911-24. doi: 10.1088/0967-3334/36/5/911. Epub 2015 Apr 9.
- Background: PubMed 24949644Khalil SF, Mohktar MS, Ibrahim F. The theory and fundamentals of bioimpedance analysis in clinical status monitoring and diagnosis of diseases. Sensors (Basel). 2014 Jun 19;14(6):10895-928. doi: 10.3390/s140610895.
- Individual participant dataSharing planned: No. There is no plans to make individual participant data (IPD) available to other researchers.
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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.
Shan-Yu Su, M.D. principal investigator
China Medical University, China
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 Pulse Wave and Pregnancy, run by China Medical University Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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 6 May 2024. 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 Taiwan. 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 Shan-Yu Su, M.D. (+886-4-22052121 ext. 4561, shanyusu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse waves (time frame: Day 1). 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 NCT05428878, which also lists 4 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 6 May 2024.