PRERISK Study: A Randomized Controlled Trial Evaluating a sFlt-1/PlGF-Based Calculator for Preeclampsia...

Area of Science:

• Obstetrics and Gynecology
• Maternal-Fetal Medicine
• Clinical Trials

Background:

• Preeclampsia poses significant maternal-fetal risks.
• A predictive model, the PRERISK calculator, was developed to assess these risks.
• The model integrates soluble Fms-like tyrosine kinase-1/placental growth factor ratio, gestational age, and urinary protein-to-creatinine ratio.

Purpose of the Study:

• To evaluate if the PRERISK calculator can reduce hospital admissions for preeclampsia patients.
• To determine if using the PRERISK score impacts complication rates.
• To assess the clinical utility of the PRERISK calculator in managing suspected or confirmed preeclampsia.

Main Methods:

• A multicenter, open-label, randomized controlled trial was conducted.
• Women with suspected or confirmed preeclampsia were randomized into intervention (PRERISK score guided admission) and control (routine care) groups.
• Co-primary outcomes included maternal-fetal complications and hospitalization ratio (≤0.05).

Main Results:

• No significant difference in complications was observed between groups in the intention-to-treat analysis (41.6% vs. 39.5%).
• The PRERISK score did not significantly reduce the hospitalization ratio (23.6% vs. 26.3%).
• In the per-protocol analysis, the intervention group showed a higher complication rate (47.8% vs. 41.7%).

Conclusions:

• Routine screening using the PRERISK score with a 5% cutoff does not decrease hospitalization rates in preeclampsia patients.
• The PRERISK calculator is not recommended for routine use in reducing admissions for preeclampsia.
• Further research may be needed to explore alternative predictive models or management strategies.