Pulse and Constitution of Pregnant Women

Pregnancy Clinical Trial

Official title:

Prediction of Pregnancy Constitutions and Pregnancy Slippery Pulse Using ANSWatch

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428878
• Other study ID #: CMUH110-REC2-144
• Status: Recruiting
• Start date: April 11, 2022
• Est. completion date: October 20, 2024

Study information

• Verified date: May 2024
• Source: China Medical University Hospital
• Contact: Shan-Yu Su, M.D.
• Phone: +886-4-22052121
• Email: shanyusu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• nonpregnant females and singleton pregnant females aged 20 - 45 years;

• no estrogen, progesterone, or ovulation inducing medications were in the past six months

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pregnancy
• Pulse Wave

Intervention

Diagnostic Test:
• ANS Watch
ANS Watch will be used to record the pulse waves Constitution questionnaire will be used to measure the constitution type

Locations

Country	Name	City	State
Taiwan	Shan-Yu Su	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Khalil 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. — View Citation

Pollonini 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. — View Citation

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. — View Citation

Zhang 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1