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Validation Study of Urinary Proteomics-Based Diagnostic Panel for Preeclampsia

Validation Study of Urinary Proteomics-Based Diagnostic Panel for Preeclampsia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129976
Enrollment
Unknown
Registered
2026-08-12
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-08-24

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

Conditions

Target disease: Preeclampsia (PE), including severe and non-severe cases Related condition: Gestational hypertension (GH), as a high-risk precursor to PE

Interventions

Preeclampsia (PE):None
Gestational Hypertension (GH):None

Sponsors

Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion Criteria for Healthy Pregnant Women and Patients: Age between 18 and 40 years; Gestational age between 20 and 38 weeks; Singleton pregnancy; Signed informed consent. Patient Inclusion Criteria: Based on the Guidelines for the Diagnosis and Treatment of Hypertensive Disorders in Pregnancy (2020). Gestational Hypertension (GH): Defined as new-onset hypertension after 20 weeks of gestation, with systolic blood pressure (SBP) >= 140 mmHg and/or diastolic blood pressure (DBP) >= 90 mmHg; Negative for proteinuria. Severe GH: SBP >= 160 mmHg and/or DBP >= 110 mmHg. Preeclampsia (PE): Defined as blood pressure > 140/90 mmHg and proteinuria >= 300 mg in a 24-hour urine collection. Severe Preeclampsia: SBP > 160 mmHg or DBP > 110 mmHg, and proteinuria > 5 g/24 hours, plus one or more of the following: Intrauterine growth restriction (IUGR) below the 10th percentile; Persistent neurological symptoms (headache, visual disturbances); HELLP syndrome: hemolysis, elevated liver enzymes (>2× normal), oliguria ( 1.0 mg/dL, or platelet count < 100,000 cells/µL.

Exclusion criteria

Exclusion criteria: 1. Pregnant women with multiple gestations; 2. Presence of severe reproductive system abnormalities or lesions.

Design outcomes

Primary

MeasureTime frame
Diagnostic performance of the urinary protein panel;

Secondary

MeasureTime frame
Differential expression of individual proteins;

Countries

China

Contacts

Public ContactShao Wenguang

Shanghai Jiao Tong University

wshao@sjtu.edu.cn+86 10 12345678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026