Pulse and Constitution of Pregnant Women

Recruiting

• Conditions: Pulse Wave; Pregnancy
• Interventions: Diagnostic Test: ANS Watch

• Registration Number: NCT05428878
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-pregnant	ANS Watch	non-pregnant women
Pregnant	ANS Watch	pregnant women

Primary Outcome Measures

Name	Time	Method
Pulse waves	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.

Secondary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Shan-Yu Su; 🇨🇳 Taichung, Taiwan