Validation Study of the MaiRa Blood Test to Predict Early and Late Preeclampsia in Pregnant Women During the First and Second Trimesters

What this Trial Is About

Researchers are evaluating the MaiRa Preeclampsia Test, a molecular screening tool designed to predict early-onset and late-onset preeclampsia PE during the first and second trimesters of pregnancy. Preeclampsia is a serious pregnancy complication with significant risks for both mother and baby. Current screening methods have limited accuracy, so this study aims to confirm the accuracy of this new test in a large group of pregnant women. The study is observational and will involve 7,473 pregnant women aged 18 or older from 12 hospitals in Spain. Blood samples will be collected three times during pregnancy first trimester 9-14 weeks, second trimester 15-26 weeks, and third trimester 27 weeks or more. The MaiRa Preeclampsia Test will analyze these samples to detect molecular markers associated with preeclampsia, and results will be compared with actual pregnancy outcomes. Participants will attend up to three visits for blood collection and clinical data gathering. Researchers will monitor the tests diagnostic accuracy by evaluating sensitivity, specificity, and predictive values. Data quality will be ensured through continuous monitoring. The study will last about 40 months, including recruitment, sample analysis, follow-up, and statistical work. The main outcome is the tests performance in first-trimester screening for early preeclampsia, with additional assessments for second-trimester detection.

Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters