NL-OMON38312
Completed
Not Applicable
Prediction of short-term outcome in pregnant women with suspected preeclampsia study - PROGNOSIS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- preeclampsia
- Sponsor
- Roche Diagnostics GmbH
- Enrollment
- 125
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women \>\=18 years
- •Gestational week 24\+0 days \- 36\+6 days
- •Signed written informed consent
- •Suspicion of clinical diagnosis of PE 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)
Exclusion Criteria
- •Proteinuria \>\=2\+ (dipstick) (or in case available \>\=0\.3 g protein/24 hours or \>\=30 mg/dL protein in spot urine or spot urine protein/creatinine ratio \>\=30 mg protein/mmol creatinine) AND elevated BP (\>\=140 mmHg systolic and/or \>\=90 mmHg diastolic, reproducible on two occasions)
- •Proteinuria \>\=2\+ (dipstick) (or in case available \>\=0\.3 g protein/24 hours or \>\=30 mg/dL protein in spot urine or spot urine protein/creatinine ratio \>\=30 mg protein/mmol creatinine) AND current anti hypertensive treatment
- •Confirmed diagnosis of HELLP syndrome
- •Concomitant participation in another clinical study (with exception of existing Biobanks as site pecifically agreed upon with RD)
- •Investigational medicinal product received in the past 3 months (90 days)
- •Employee at the investigational site, or relative or spouse of the investigator
Outcomes
Primary Outcomes
Not specified
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