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Protocol for the ECLIPSE-BRAZIL: a prospective cohort study on biomarkers and risk stratification for Preeclampsia
Ana Luísa Torres Tavares1, Vanessa Duarte Pasa1, Jesiel Francisco de Jesus Fernandes Martins Lima1
1Department of Clinical and Toxicological Analysis, School of Pharmacy, Federal University of Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
Insights
The ECLIPSE-BRAZIL study identifies biomarkers for early preeclampsia (PE) prediction in pregnant women. This research aims to improve diagnosis and management of PE, a major cause of maternal mortality.
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Clinical Research
Background:
- Preeclampsia (PE) is a significant global cause of maternal and perinatal mortality, especially in low- and middle-income countries.
- Current understanding of PE etiology and pathogenesis is incomplete, and effective predictive biomarkers are lacking.
- The ECLIPSE-BRAZIL study addresses these gaps by investigating PE in a Brazilian cohort.
Purpose of the Study:
- To identify cost-effective biomarkers for early and accurate prediction of preeclampsia risk in pregnant women.
- To elucidate the genetic, immunological, hemostatic, biochemical, and angiogenic profiles associated with PE development.
- To improve the prediction, diagnosis, and management of preeclampsia through novel health innovations.
Main Methods:
- Prospective cohort study involving 500-1,000 pregnant women at high risk for PE in Brazil.
- Systematic collection of clinical, sociodemographic, behavioral, blood, and urine data at multiple gestational stages and postpartum.
- Comprehensive analysis of inflammatory markers, angiogenic factors, oxidative stress, extracellular vesicles, microRNAs, and endothelial/platelet markers.
Main Results:
- The study is ongoing, focusing on systematic data collection and biomarker analysis.
- Stratification of participants by PE development and gestational age at diagnosis ensures robust analysis.
- Rigorous data protocols, quality checks, and frequent participant contact minimize loss to follow-up.
Conclusions:
- ECLIPSE-BRAZIL will offer new insights into PE pathophysiology and improve disease prediction and management.
- Findings will inform the development of cost-effective diagnostic tools, point-of-care tests, and clinical algorithms for early PE risk identification.
- The study aims to uncover novel therapeutic targets by deepening the understanding of PE's biological mechanisms and subtypes.
Background:
Preeclampsia (PE) is a leading cause of maternal and perinatal morbimortality, particularly in low- and middle-income countries. Despite advances in clinical management, its etiology and pathogenesis remain unclear, and effective predictive biomarkers are lacking. The Brazilian Longitudinal Study for the Investigation of Preeclampsia (ECLIPSE-BRAZIL) is a prospective cohort designed to investigate genetic, immunological, hemostatic, biochemical, and angiogenic profiles in pregnant women at risk for PE, aiming to identify biomarkers that effectively and affordably predict PE risk early in pregnancy.
Methods:
ECLIPSE-BRAZIL follows 500 to 1,000 pregnant women receiving care at the High-Risk Prenatal Care clinics in Belo Horizonte and Divinópolis, Minas Gerais, Brazil. Clinical and laboratory assessments are conducted at four gestational stages and postpartum for PE cases. Clinical data, including sociodemographic, clinical and behavioral factors, and blood and urine samples are systematically collected. Plasma and urine levels of inflammatory markers, angiogenic factors, oxidative stress parameters, extracellular vesicles, microRNAs, endothelial and platelet markers will be analyzed. Participants are stratified by PE development and gestational age at diagnosis. Standardized criteria and data protocols ensure rigor, while quality check and audits enhance data reliability. To minimize follow-up loss, participants are contacted frequently, with flexible sampling and the use of hospital records.
Discussion:
ECLIPSE-BRAZIL will provide novel insights into PE pathophysiology, improving disease prediction and management. By studying a diverse population, we will identify biological signatures to inform health innovations: development of cost-effective diagnostic tools, point-of-care tests and simple clinical algorithms to identify women at risk before symptoms become severe. Finally, we will provide a deeper understanding of biological mechanisms driving PE and its subtypes, including endothelial function and immune response, which may lead to the discovery of new therapeutic targets. ECLIPSE-BRAZIL represents a major advancement in PE research, integrating a comprehensive evaluation of clinical, biochemical, and molecular markers throughout pregnancy. Its findings may inform public health policies and improve clinical practices worldwide.
Trial Registration:
Not applicable. This is an observational cohort study approved by the Research Ethics Committees, as documented under the following CAAE numbers: 12471918.0.0000.5149, 12471918.0.3002.5119, 12471918.0.3003.5130, 12471918.0.3006.5545.
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