First-Trimester Sequential Screening for Preeclampsia Using Angiogenic Factors: Study Protocol for a Prospective,...

Area of Science:

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

Background:

• Preeclampsia (PE) affects 2-8% of pregnancies, causing significant maternal and neonatal morbidity and mortality.
• Low-dose aspirin prophylaxis reduces early-onset PE, intrauterine growth restriction (IUGR), and neonatal intensive care unit (ICU) stays.
• Current universal first-trimester screening using angiogenic markers (PlGF, sFlt-1) is effective but costly.

Purpose of the Study:

• To evaluate a novel two-step sequential screening model for predicting preeclampsia (PE) in the first trimester.
• To assess the predictive and preventive capacity of this model in a real-world clinical setting.
• To determine if this model achieves similar diagnostic performance to universal PlGF testing at a lower economic cost.

Main Methods:

• Prospective, multicentric, cohort study in a real-world clinical setting.
• First-trimester risk assessment using a multivariate model (medical history, blood pressure, PAPP-A, UTPI).
• Sequential screening: PlGF testing only for intermediate-risk patients; aspirin prophylaxis for high-risk individuals.

Main Results:

• The study hypothesizes that the sequential screening model will have comparable diagnostic performance to universal PlGF testing.
• The model aims to identify high-risk pregnancies for early intervention with aspirin.
• Secondary analysis will assess sFlt-1 performance in high and intermediate-risk groups.

Conclusions:

• The proposed two-step sequential screening model offers a potentially cost-effective approach to early preeclampsia detection.
• This strategy aims to optimize resource allocation in prenatal care while maintaining high diagnostic accuracy.
• Early identification and intervention can mitigate the adverse outcomes associated with preeclampsia.