Biomarkers and Preeclampsia Outcomes

Dacima Consulting600 enrolled

Overview

Prospective, observational, monocentric, non-interventional study.

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Preeclampsia

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Suspected or confirmed preeclampsia * Singleton pregnancy * Between 26 weeks of gestation and 37 weeks of gestation \& 6 days Exclusion Criteria: * Multiple pregnancies

Locations (1)

Maternity Center of Tunis

Tunis, Tunisia

Outcomes

Primary Outcomes

Biomarkers ratio

sFlt-1/PlGF ratio

Time frame: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia

Secondary Outcomes

Biomarkers ratio

sFlt-1/PlGF ratio

Time frame: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia

Biomarkers ratio

sFlt-1/PlGF ratio

Time frame: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia

Maternal outcome

Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.

Time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks

Fetal outcome

Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR \< 7, or Prematurity)

Time frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks

Fetal outcome

Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR \< 7, or Prematurity

Time frame: Date of delivery

Data from ClinicalTrials.gov

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