Trials / Completed
CompletedNCT03801447
Biomarkers and Preeclampsia Outcomes
Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 600 (actual)
- Sponsor
- Dacima Consulting · Academic / Other
- Sex
- Female
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, observational, monocentric, non-interventional study.
Detailed 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)
Conditions
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2019-01-11
- Last updated
- 2022-08-22
Locations
1 site across 1 country: Tunisia
Source: ClinicalTrials.gov record NCT03801447. Inclusion in this directory is not an endorsement.