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

Roche Diagnostics GmbH0 个研究点目标入组 125 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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%.

•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

发起方