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Clinical Trial on the Accuracy of the Fish YE680B Arm-Cuff Electronic Blood Pressure Monitor in Measuring Blood Pressure Among Pregnant Women and Those with Preeclampsia

Clinical trial on the accuracy of blood pressure measurement using the YuWell YE680B arm electronic blood pressure monitor in pregnant women and individuals with preeclampsia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115231
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-12-28
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood pressure

Interventions

Gold Standard:This study mainly uses a mercury column sphygmomanometer to verify the validity period of electronic blood pressure measurement. Mercury column blood pressure has always been the "gold s
Index test:YE680B Upper Arm Electronic Blood Pressure Monitor

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age requirement Women over 18 years old in the middle and late stages of pregnancy (mid pregnancy: 13-27 weeks, late pregnancy: 28 weeks and beyond) 2. Blood pressure distribution requirements (1) At least 28 pregnant women with normal blood pressure (systolic blood pressure=140mmHg and/or diastolic blood pressure >=90mmHg, and 24-hour proteinuria=140mmHg and/or diastolic blood pressure >=90mmHg, accompanied by proteinuria, 24-hour proteinuria>300mg). 3. Voluntarily participate in this clinical trial and sign an informed consent form; 4. Good compliance and ability to cooperate in completing the entire clinical trial.

Exclusion criteria

Exclusion criteria: 1. Individuals with mental illness or those who cannot cooperate quietly (speaking/moving during the measurement process); Subjects who may have difficulty measuring blood pressure due to skin or limb reasons; 2. Individuals undergoing dialysis treatment or taking anticoagulants, antiplatelet agents, steroids, and other medications; 3. Those outside the coverage range of arm cuff size; Or subjects who have difficulty measuring blood pressure while sitting; 4. Patients with arrhythmia (arrhythmia that may affect the accuracy of blood pressure measurement as determined by the researcher; excluding sinus tachycardia that is common during pregnancy and the researcher believes does not affect measurement); 5. Patients with peripheral arterial disease and diseases that may affect arterial compliance; 6. Smoking, drinking coffee or not emptying the bladder within 30 minutes before measurement; 7. The doctor believes that there are other situations that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Mean error and standard deviation;Consistency between experimental blood pressure monitor and reference blood pressure values;The relationship between arm circumference and measurement error;

Secondary

MeasureTime frame
Relative error of pulse frequency;Safety evaluation;

Countries

China

Contacts

Public ContactYin Zongzhi

The First Affiliated Hospital of Anhui Medical University

dr_yinzongzhi@qq.com+86 551 6292 3430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026