Pulse and Constitution of Pregnant Women

NCT ID: NCT05428878

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-11

Study Completion Date

2024-10-20

Brief Summary

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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

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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

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Pulse Wave Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pregnant

pregnant women

ANS Watch

Intervention Type DIAGNOSTIC_TEST

1. ANS Watch will be used to record the pulse waves
2. Constitution questionnaire will be used to measure the constitution type

Non-pregnant

non-pregnant women

ANS Watch

Intervention Type DIAGNOSTIC_TEST

1. ANS Watch will be used to record the pulse waves
2. Constitution questionnaire will be used to measure the constitution type

Interventions

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ANS Watch

1. ANS Watch will be used to record the pulse waves
2. Constitution questionnaire will be used to measure the constitution type

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Constitution questionnaire

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shan-Yu Su, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

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Shan-Yu Su

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shan-Yu Su, M.D.

Role: CONTACT

+886-4-22052121 ext. 4561

Facility Contacts

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Shan-Yu Su Su, M.D.

Role: primary

+886-920125943 ext. 4561

References

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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.

Reference Type BACKGROUND
PMID: 25223771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21593741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25856085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24949644 (View on PubMed)

Other Identifiers

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CMUH110-REC2-144

Identifier Type: -

Identifier Source: org_study_id

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