preeclampsia toxemia
Conditions
Interventions
P/Cr ratio (protein/creatinine ratio)
PlGF (Placental Growth Factor)
Prediction
Preeclampsia
sFlt-1 (Soluble Fms-like tyrosine kinase 1)
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Age * 16 years;2) Gestational age of at least 20 weeks and 0 days;3) Signed written informed consent;4) Suspected preeclampsia as a protocol defined definition , based on one or more of the following criteria: - New onset of elevated blood pressure (BP) - Aggravation of preexisting hypertension - New onset of protein in urine - Aggravation of preexisting proteinuria - One or more other reason(s) for clinical suspicion of PE: * PE-related symptoms: epigastric pain, excessive edema, severe swelling (face, hands, feet), headache, visual disturbances, sudden weight gain (>1 kg/week) * PE-related findings: low platelets, elevated liver transaminases, IUGR (Intra-uterine growth restriction);OR;5) Confirmed preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
Exclusion criteria
Exclusion criteria: 1) Insufficient understanding of Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will assess the false-negative rate when predicting the absence of preeclampsia within one week as the primary objective. | — |
Secondary
| Measure | Time frame |
|---|---|
| Thereby, safety and efficacy analysis will include the potential influence of the test on clinical decision making (i.e. hospitalization, home-monitoring or discharge). | — |
Countries
The Netherlands
Outcome results
None listed