Biomarkers and Preeclampsia Outcomes (REPORTS)

DACIMA

Status: Completed

Conditions: Preeclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT03801447

DAC-003-REPORTS

Details and patient eligibility

About

Prospective, observational, monocentric, non-interventional study.

Full 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)

Enrollment: 600 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected or confirmed preeclampsia
• Singleton pregnancy
• Between 26 weeks of gestation and 37 weeks of gestation & 6 days

Exclusion criteria

• Multiple pregnancies