Clinical trial NCT05428878: Pulse and Constitution of Pregnant Women
Official title: Prediction of Pregnancy Constitutions and Pregnancy Slippery Pulse Using ANSWatch
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulse Wave
Pregnancy
Keywords: pregnant women
pulse
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females aged 20-45 years with a pregnant condition or a non-pregnant condition.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulse waves
timeFrame: Day 1
Secondary outcomes:
measure: Constitution
timeFrame: Day 1
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Shan-Yu Su
Study officials:
affiliation: China Medical University, China
name: Shan-Yu Su, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.