Biomarkers and Preeclampsia Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03801447

Acronym

REPORTS

Enrollment

600

Registered

2019-01-11

Start date

2018-04-01

Completion date

2022-06-30

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Brief 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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Biomarkers ratio	Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia	sFlt-1/PlGF ratio

Secondary

Measure	Time frame	Description
Biomarkers ratio	Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia	sFlt-1/PlGF ratio
Maternal outcome	From date of inclusion until the date of first documented event, assessed up to 24 weeks	Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.
Fetal outcome	From date of inclusion until the date of first documented event, assessed up to 24 weeks	Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR \< 7, or Prematurity)

Countries

Tunisia

Outcome results