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Biomarkers and Preeclampsia Outcomes — REPORTS  

Preeclampsia Clinical Trial

Official title:
Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS

Clinical Trial Summary

Prospective, observational, monocentric, non-interventional study.

Clinical Trial Description

In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs & symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage. REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women. Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03801447
Study type Observational
Source Dacima Consulting
Contact
Status Completed
Phase
Start date April 1, 2018
Completion date June 30, 2022
View Details
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