Recerca, Salut materna, infantil i reproductiva

Evaluación de la eficacia del ácido acetilsalicílico a dosis bajas en la prevención de los efectos maternos y perinatales adversos en mujeres embarazadas infectadas por el SARS-CoV-2

Durada: 01/01/2023 - 31/12/2025
Coordinador: Clara Menéndez
Finançadors: Proyecto PI22/01828

La infección por SARS-CoV-2 durante la gestación está asociada con un incremento en los resultados adversos maternos y perinatales. Una posible explicación es que la infección podría incrementar el estado protrombótico asociado a la gestación, conduciendo a un mayor riesgo de complicaciones placentarias y vasculares. La administración de ácido acetilsalicílico a dosis bajas ha demostrado mejorar los resultados maternos y perinatales en mujeres con alto riesgo de complicaciones endoteliales y placentarias. Sin embargo, no existen datos acerca del efecto del ácido acetilsalicílico a dosis bajas para prevenir complicaciones en mujeres embarazadas infectadas por el SARS-CoV-2.

Para reducir las complicaciones asociadas con el SARS-CoV-2 en un grupo muy vulnerable a la infección, llevaremos a cabo este ensayo clínico multicéntrico, doble ciego, controlado con placebo en 400 mujeres embarazadas infectadas por el SARSCoV-2.

El objetivo principal del estudio es evaluar la eficacia y seguridad del ácido acetilsalicílico a dosis baja administrado hasta la semana 36 de gestación en mujeres embarazas infectadas por el SARS-CoV-2 para reducir la incidencia de resultados maternos y perinatales adversos. Las mujeres embarazadas que sean positivas en un test rápido antigénico o test PCR para SARS-CoV-2 hasta la semana 32 de gestación y que acepten participar serán randomizadas 1:1 a recibir diariamente ácido acetilsalicílico a dosis baja (125mg) o placebo hasta la semana 36 de embarazo y se les hará seguimiento hasta el parto.

Financiación

153.670 €

Coordinadora

Clara Menéndez Research Professor, Directora de la Iniciativa i del Programa de Salut Materna, Infantil i Reproductiva

Equipo ISGlobal

Candelaria Serrano Clinical Trial Manager
Andreu Bofill Data Manager
Linda Stoeger Research Assistant
MIREIA PIQUERAS Project Manager
Laura García Medical Research Fellow

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