First-Trimester Sequential Screening for Preeclampsia Using Angiogenic Factors : Study Protocol for a Prospective, Multicenter, Real Clinical Setting Study
Trilla, Cristina (Institut d'Investigació Biomèdica Sant Pau)
Luna, Cristina (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
De León Socorro, Silvia (Complejo Hospitalario Universitario Insular)
Rodriguez, Leire (Osakidetza)
Ruiz-Romero, Aina (Hospital Universitari Son Llàtzer (Palma de Mallorca, Balears))
Mora Brugués, Josefina (Hospital de la Santa Creu i Sant Pau (Barcelona, Catalunya))
Benítez Delgado, Taysa (Complejo Hospitalario Universitario Insular)
Fabre, Marta (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Martin Martínez, Alicia (Complejo Hospitalario Universitario Insular)
Ruiz-Martinez, Sara (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Llurba, E (Institut d'Investigació Biomèdica Sant Pau)
Oros, Daniel (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	The incidence of preeclampsia (PE) is about 2-8%, making it one of the leading causes of perinatal morbidity and maternal mortality in the world. Early prophylactic low dose administration (150 mg) of acetylsalicylic acid is associated with a significant reduction in the incidence of early-onset PE, intrauterine growth restriction (IUGR), and neonatal mean stay in the intensive care unit (ICU). Universal implementation of a first-trimester screening system including angiogenic and antiangiogenic markers [the Placental Growth Factor (PlGF) and/or soluble fms-like Tyrosine Kinase-1 (sFlt-1)] has shown a prediction rate of 90% for early-onset PE but entails a high financial cost. The aim of this study is to determine the predictive and preventive capacity of a universal PE first-trimester two-step sequential screening model, determining the PlGF only in patients previously classified as intermediate risk by means of a multivariate model based on resources already used in the standard pregnancy control, in a real clinical setting. We hypothesize that this screening model will achieve similar diagnostic performance as the universal determination of PlGF but at a lower economic cost. This is a prospective, multicentric, cohort study in a real-world clinical setting. Every singleton pregnancy will be recruited at the routine first pregnancy visit. In a first step, the first-trimester risk of PE will be calculated using a multivariate Gaussian distribution model, based on medical history, mean blood pressure, Pregnancy-Associated Plasma Protein A (PAPP-A), and Uterine Artery Doppler Pulsatility Index (UTPI). Patients will be classified into three risk groups for PE: (1) risk ≥ 1/50, high-risk with no further testing (blinded PlGF); (2) risk between 1/51 and 1/500, medium-risk requiring further testing; and (3) risk ≤ 1/501, low-risk with no further testing. In a second step, the PlGF will only be determined in those patients classified as intermediate risk after this first step, and then reclassified into high- or low-risk groups. Prophylactic administration of aspirin (150 mg/day) will be prescribed only in high risk patients. As a secondary objective, sFlt-1 values will be blindly determined in patients with high and intermediate risk to assess its potential performance in the screening for PE. The study will be conducted in accordance with the principles of Good Clinical Practice. This study is approved by the Aragon Research Ethics Committee (CEICA) on 3 July 2020 (15/2020). , identifier: NCT04767438.
Grants:	Instituto de Salud Carlos III PI19/00692
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	First trimester ; Growth restriction ; Preeclampsia ; Screening ; Sequential
Published in:	Frontiers in Cardiovascular Medicine, Vol. 9 (july 2022) , ISSN 2297-055X

DOI: 10.3389/fcvm.2022.931943
PMID: 35958398

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