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 : Recruiting
First Posted : July 27, 2017
Last Update Posted : July 11, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||February 6, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: Incorporation of the sFlt1/P1GF ratio
Incorporation of the ratio in the diagnosis and classification of pre-eclampsia:
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
- 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.
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
|Contact: Elisa Llurba, MD, PhDfirstname.lastname@example.org|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Elisa Llurba, MD, PhD +34935537041 email@example.com|
|Principal Investigator:||Elisa Llurba, MD, PhD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|