Comparison of glycosylated fibronectin test (Lumella®) with sFLT/PLGF ratio test for assessment of pre-eclampsia

Advanced Global Health0 个研究点目标入组 400 人开始时间: 2023年11月10日最近更新: 2023年12月12日

适应症

试验速览

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•Potential participants include cases with a risk of preeclampsia who meet the following criteria at the time of enrolment:
•1. Age of 18 years or older
•2. Singleton or twin pregnancy
•3. Gestational age between 24+0 to 36+6 weeks
•4. Able to provide informed written consent
•5. Planned delivery at the study site or where maternal and newborn records will be available to the investigator for review
•Cases with a risk of preeclampsia will be identified based on clinical and medical history criteria as follows:
•Clinical risk factors:
•1. Systolic blood pressure =130 mmHg on 1 or more occasion
•2. Diastolic blood pressure =80 mmHg on 1 or more occasion
•3. Elevated urinary protein:
•3.1. Urine protein dipstick test 1+ or more
•3.2. Urinary protein/creatinine ratio =0.30 mg/mg
•3.3. Urinary protein =300 mg per day in timed collection
•4. New onset low platelet count =100,000 x 109/L
•5. New onset elevated serum creatinine =1.0 mg/dL
•6. New onset transaminase elevation above limits of normal for local laboratory
•7. New-onset headache unresponsive to medication and not accounted for by alternative diagnoses
•8. New onset visual symptoms
•9. Fetal growth restriction with estimated fetal weight below 10th percentile
•Historical/obstetrical risk factors:
•1. History of preeclampsia
•2. Multifetal pregnancy
•3. Pre-existing hypertension
•4. Pre-gestational diabetes mellitus
•5. Pre-existing renal disease

•1. Diagnostic criteria for preeclampsia already met at the time of enrolment
•2. Delivery is planned prior to 37+0 weeks of gestation for reasons other than preeclampsia

发起方

Advanced Global Health