Prediction of short-term outcome in pregnant women with suspected preeclampsia study

Completed

• Conditions: preeclampsia; 10010273

• Registration Number: NL-OMON38312
• Lead Sponsor: Roche Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 125

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)
• PE-related findings: low platelets, elevated liver transaminases, IUGR (Intra-uterine growth restriction) or abnormal uterine perfusion detected by Doppler sonography with mean PI > 95th percentile in second trimester and/or bilateral notch
Note: percentage of women with suspected PE due to abnormal uterine perfusion at each site shall not exceed 25%.

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Value of the sFlt-1/PlGF ratio at Visit 1 to predict PE / eclampsia / HELLP<br /><br>(according to diagnostic criteria) within one and four weeks from Visit 1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>