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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)

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ClinicalTrials.gov Identifier: NCT03231657
Recruitment Status : Not yet recruiting
First Posted : July 27, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief 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.


Condition or disease Intervention/treatment Phase
Preeclampsia Diagnostic Test: Placental biomarkers Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Estimated Study Start Date : December 29, 2017
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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….)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231657


Contacts
Contact: Elisa Llurba, MD, PhD +34935537041 ellurba@santpau.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08025
Contact: Elisa Llurba, MD, PhD    +34935537041    ellurba@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Carlos III Health Institute
Investigators
Principal Investigator: Elisa Llurba, MD, PhD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications:
National Institute for Health and Care Excellence guideline DG 23 (2016): PlGF based testing to help diagnose suspected pre-eclampsia (Triage PlGF test, Elecsys immunoassay sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test, and BRHAMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio). Available at: https://www.nice.org.uk/guidance/dg23/chapter/1-recommendations [Accessed January 2017].

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03231657     History of Changes
Other Study ID Numbers: IIBSP-EUR-2017-20
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
preeclampsia
intrauterine growth restriction
angiogenic factors

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications