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

Not Applicable

Completed

• Conditions: Preeclampsia
• Interventions: Diagnostic Test: Placental biomarkers

• Registration Number: NCT03231657
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-27
• Study Start: 2018-02-06
• Primary Completion: 2022-06-21
• Status Verified: 2022-08
• Study Completion: 2023-11-11
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2536

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incorporation of the sFlt1/P1GF ratio	Placental biomarkers	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

Primary Outcome Measures

Name	Time	Method
Adverse outcomes	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.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain