Preeclampsia Risk Assessment: Evaluation of Cut-Offs to Improve Stratification (PRAECIS) Methods for a Multi-Center, Prospective Cohort Study in Biomarkers for Preeclampsia in the United States

Abstract

Purpose: To describe the methods and protocol outline of the PRAECIS study, which aims to identify and validate a cut-off of the ratio of the FMS-like tyrosine kinase-1 soluble protein (sFLT-1) and placental growth factor (PlGF) to predict the short-term (2 week) development of severe features requiring delivery per the guidelines of the American College of Obstetricians and Gynecologists in hospitalized, adult women with a known hypertensive disorder of pregnancy between 23 weeks and 34 weeks and 6 days gestational age. Methods: The PRAECIS study is a pragmatic, observational, blinded multi-center study to identify and validate a cut-off of the sFLT-1/PlGF ratio in hospitalized women with preterm, hypertensive disorders of pregnancy that will predict the short-term (2 week) development of preeclampsia with severe features. The study aims to provide the definitive American data necessary for application of the serum prognostic test to the FDA for approval in the US. Conclusions: The PRAECIS study is a feasible study design across academic and community centers in the United States and promises the necessary data to bring a much anticipated serum prognostic device to American obstetric clinics.