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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38312

Enrollment

125

Registered

2011-05-23

Start date

2011-09-05

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

preeclampsia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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) • 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

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

Design outcomes

Primary

Measure	Time frame
Value of the sFlt-1/PlGF ratio at Visit 1 to predict PE / eclampsia / HELLP (according to diagnostic criteria) within one and four weeks from Visit 1.	—

Countries

Netherlands

Outcome results