Vinaros

Preeclampsia (PE) is a serious pregnancy complication that can have severe effects on both mother and baby. Early detection is important to reduce risks and improve outcomes. Current screening methods often focus on placental biomarkers and maternal factors but have limited sensitivity, especially in the first trimester. Recent research using cell free RNA (cf-RNA) has led to the development of the MaiRa Preeclampsia Test, which shows promise in predicting both early- and late-onset preeclampsia during pregnancy. This study is a multicenter, prospective observational trial designed to validate the MaiRa Preeclampsia Test in predicting early-onset and late-onset preeclampsia during the first and second trimesters. The study will recruit 7,473 pregnant women from 12 hospitals in Spain and will collect maternal blood samples at three points during pregnancy: 9-14 weeks, 15-26 weeks, and at or after 27 weeks. These samples will be analyzed with the MaiRa Test and correlated with pregnancy outcomes. Participants will have their blood drawn during three visits in pregnancy, and clinical data will also be recorded in an electronic system. The study will monitor data quality continuously. Researchers will evaluate the test's accuracy by measuring sensitivity, specificity, predictive values, and other statistical outcomes. The study will last 30 months, including recruitment, sample analysis, follow-up, and reporting.