Pulse and Constitution of Pregnant Women

Sponsor
China Medical University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05428878
Collaborator
(none)
200
1
11.7
17.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ANS Watch

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Prediction of Pregnancy Constitutions and Pregnancy Slippery Pulse Using ANSWatch
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pregnant

pregnant women

Diagnostic Test: ANS Watch
ANS Watch will be used to record the pulse waves Constitution questionnaire will be used to measure the constitution type
Other Names:
  • Constitution questionnaire
  • Non-pregnant

    non-pregnant women

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

    Primary Outcome Measures

    1. Pulse waves [Day 1]

      indices of the pulse waves measured by ANSWatch (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.

    Secondary Outcome Measures

    1. Constitution [Day 1]

      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 Neuture constitutions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shan-Yu Su Taichung Taiwan 404

    Sponsors and Collaborators

    • China Medical University Hospital

    Investigators

    • Principal Investigator: Shan-Yu Su, M.D., China Medical University, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    China Medical University Hospital
    ClinicalTrials.gov Identifier:
    NCT05428878
    Other Study ID Numbers:
    • CMUH110-REC2-144
    First Posted:
    Jun 23, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by China Medical University Hospital

    Study Results

    No Results Posted as of Jun 23, 2022