preeclampsia
Conditions
Interventions
Gold Standard:The gold standard for clinical diagnosis of preeclampsia is: new hypertension (systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg) after 20 weeks of pregnancy with
? Renal impairment (serum creatinine >1.1 mg/dL or > 97.2µmol/L)
? Pulmonary edema
(5) New abnormalities of the central nervous system or visual disturbances.
Index test:Urine misfolded protein and Congo red binding test, the test dish colored red defined positive, colorless defined negative.
Sponsors
Department of Obstetrics and Gynecology, Women's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old 2. Gestational age 20+0 to 33+6 3. Single pregnancy 4. Clinically suspected preeclampsia meets one or more of the following criteria: (1) New hypertension (systolic =130 mmHg and/or diastolic =80 mmHg); (2) Increased blood pressure (non-hypertensive patients increased more than 30/15 mmHg from the basic blood pressure, hypertensive patients showed a significant increase trend or beyond controlled based on the original treatment); (3) New proteinuria (no urinary tract infection and urinary protein =1+); (4) One or more clinical symptoms showed suspected preeclampsia (other possible causes have been ruled out).
Exclusion criteria
Exclusion criteria: (1) Diagnosed preeclampsia/chronic hypertension with preeclampsia (2) Diagnosed eclampsia (3) Diagnosed HELLP syndrome (4) Fetal chromosomal abnormalities (5) Participating in another drug clinical study (6) Received investigational intervention drugs within 3 months (7) Hematuria (8) History of nephropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of preeclampsia;Accuracy;Sensitivity;Specificity;Positive predicative value; | — |
Countries
China
Contacts
Public ContactBai Xiaoxia
Department of Obstetrics and Gynecology, Women's Hospital, Zhejiang University School of Medicine
Outcome results
None listed