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 (EuroPE)

December 19, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 (EuroPE Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2536

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu I Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to read and understand informed consent.
  • Unique pregnancies.
  • > 24 weeks and <41 weeks

  • Suspected preeclampsia:

    1. 140/90 or worsening of chronic hypertension
    2. Onset of proteinuria (Labstick + or proteinuria> 300mg / 24 hours) or worsening of it
    3. Preeclampsia prodromal clinic such as epigastric, headache, photopsia, tinnitus and increased edema in the face hands or legs or weight gain (> 1 kg per week in the third trimester)
    4. Analytical alterations: decrease in platelets <100,000. Increased transaminases.
    5. Ultrasound alterations: Small fetus for gestational age or restriction of interatrial growth, increased resistance of the uterine arteries.
  • Pre-eclampsia (ACOG Practice Bulletin 2013)

Exclusion Criteria:

  • Multiple pregnancies
  • <24 weeks of gestation
  • Fetal chromosomal or congenital abnormalities
  • Conditions that require immediate delivery (eclampsia, pulmonary edema, uncontrolled hypertension, severe visual disturbances, severe headache, fetal demise, non-reassuring fetal status….)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incorporation of the sFlt1/P1GF ratio

Incorporation of the ratio in the diagnosis and classification of pre-eclampsia:

  • sFlt1/PlGF ratio >38: pre-eclampsia risk
  • sFlt1/PlGF ratio >85: pre-eclampsia
  • ISSHP pre-eclampsia definition + ratio >210: severe PE
  • ISSHP pre-eclampsia definition + ratio sFlt1/PlGF ratio >600: consider deliver
Diagnostic test: Placental biomarkers
sFlt1 and P1GF levels and sFlt1/PlGF ratio
No Intervention: Routine clinical practice
Criteria for the definition of PE were those of the International Society for the Study of Hypertension in Pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse outcomes
Time Frame: Up to 24 weeks
Composite score for adverse outcomes defined as the presence of any of the following: premature placental abruption, cessation of abnormal CTG, fetal death, need for 2 or more antihypertensive drugs, eclampsia, disseminated intravascular coagulation, maternal mortality, postpartum haemorrhage (need for more than 2 concentrated hematies), acute pulmonary edema, cerebral vascular hemorrhage, pulmonary embolism, sepsis, ICU admission, need for second surgery.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Carlos III Health Institute
Spanish Clinical Research Network - SCReN

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2018

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-EUR-2017-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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