Randomizated Open-label Control Trial to Evaluate if the Incorporation of sFlt1/PlGF Ratio in the Diagnosis and Classification of PE Improves Maternal and Perinatal Outcomes in Women With the Suspicion of the Disease

Summary

Preeclampsia is a leading cause of maternal and neonatal morbidity and mortality worldwide. The morbidity and mortality of this condition arises from two main causes: 1) the lack of specific and sensible methods for its diagnosis and prognosis, 2) and the fact that the course of the disease is often unpredictability at its presentation and speed of progression. The majority of deaths are undoubtedly avoidable and are due to a substandard care. Nowadays it's known that preeclampsia is a placental disorder that is characterized by an unbalance of angiogenic and antiangiogenic factors. It has been recently proven that the ratio of sFlt-1 to PlGF in women who presented with a clinical suspicion of preeclampsia is useful distinguishing between women in whom preeclampsia would develop and those in whom it would not. A low ratio also predicted the absence of fetal adverse outcomes in the same time frame. In addition this ratio demonstrated to be useful to discriminate among patients that would developed maternal or fetal adverse outcome. Correct identification and diagnosis of women at risk could potentially prevent all these adverse outcomes thus, clinical experience suggests that early detection and monitoring are beneficial.

EuroPE aims to provide evidence that the re-definition of pre-eclampsia as an entity caused by a placental unbalance of angiogenic and anti-angiogenic factors and its incorporation in the diagnosis and classification of the disease would improve maternal and neonatal health.

This will be an open, multicentre, international, randomised controlled trial with an intention-to -treat analysis. The study is pragmatic: it will be undertaken to reflect real clinical practice rather than the very tightly controlled circumstances of explanatory trials. The main objective of this study is to determine the effects of the use of the ratio as a diagnostic tool in the definition and classification of PE, as compared with its usual definition, in triage and delivery decisions and to see whether this new approach is able to improve maternal and perinatal outcomes.

Conditions

• Preeclampsia

Interventions

DIAGNOSTIC_TEST

Placental biomarkers

sFlt1 and P1GF levels and sFlt1/PlGF ratio

Sponsors & Collaborators

• Carlos III Health Institute

  collaborator OTHER_GOV

• Spanish Clinical Research Network - SCReN

  collaborator NETWORK

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Principal Investigators

• Elisa Llurba, MD, PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-06

Primary Completion

2022-06-21

Completion

2023-11-11

Countries

• Spain

Study Locations