Pulse and Constitution of Pregnant Women

May 2, 2024 updated by: China Medical University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • Shan-Yu Su
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Females aged 20-45 years with a pregnant condition or a non-pregnant condition.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant
pregnant women
Diagnostic test: ANS Watch
  1. ANS Watch will be used to record the pulse waves
  2. Constitution questionnaire will be used to measure the constitution type
Other Names:
  • Constitution questionnaire
Non-pregnant
non-pregnant women
Diagnostic test: ANS Watch
  1. ANS Watch will be used to record the pulse waves
  2. Constitution questionnaire will be used to measure the constitution type
Other Names:
  • Constitution questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constitution
Time Frame: 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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

October 20, 2024

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH110-REC2-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plans to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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