Pregnancy
Conditions
Interventions
Gold Standard:1. Pregnancy: Gestational weeks 4–6, with positive urine or serum ß-hCG
or Gestational weeks 7–14, with ultrasound-confirmed viable intrauterine pregnancy. 2. Non-pregnancy: regular menstrual cycles in the past 3 months, and negative urine or serum ß-hCG within 7 days be
Index test:Light-Contact Pulse Diagnostic Devices
Sponsors
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18–45 years; 2. Pregnancy group: Gestational weeks 4–6, with positive urine or serum ß-hCG, and either no ultrasound performed or ultrasound showing no evidence of pregnancy; or Gestational weeks 7–14, with ultrasound-confirmed viable intrauterine pregnancy. Or non-pregnancy group: regular menstrual cycles in the past 3 months, no missed menstruation prior to enrollment, and negative urine or serum ß-hCG within 7 days before enrollment; 3. Voluntary participation with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe heart disease, vascular disease, or other systemic disorders; 2. Skin lesions, infections, or other local conditions at the wrist that preclude device placement; 3. Fasting for more than 4 hours, or within 1 hour after a meal (excluding minimal water intake); 4. Inability to understand the study or cooperate with the examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data of Light-Contact Pulse Diagnostic Devices;Overall Agreement Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, Cohen's Kappa coefficient; | — |
Countries
China
Contacts
Public ContactXiao Jing
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed