SARS-CoV-2 infection in pregnancy is associated with poor maternal and perinatal outcomes.
One explanation is the pregnancy-associated prothrombotic status, which may increase during
infection, leading to placental and vascular complications. Administration of low-dose
acetylsalicylic acid (LDASA) has shown to improve maternal and perinatal outcomes in women at
high-risk of endothelial and placental complications. However, there are no data on the
effect of adding LDASA to low molecular weight heparin (LMWH)-which is the standard of care-
in preventing complications in SARS-CoV-2- infected pregnant women. This is a randomized,
double-blinded, placebo-controlled multicentre trial including 398 SARS-CoV-2-infected
pregnant women with the main objective of evaluating the efficacy of adding daily LDASA to
low molecular weight heparin (LMWH) from the first or second trimester up to 36 weeks'
gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal
and perinatal outcomes. Pregnant women undergoing routine first or second trimester blood
tests will have a SARS-CoV-2 rapid antigen test done if they agree to participate. Women with
a positive SARS-CoV-2 rapid antigen test will be further tested with a confirmatory
SARS-CoV-2 PCR test. In case of being also positive for the SARS-CoV-2 PCR test, she will be
randomised 1:1 to receive, additionally to LMWH for at least 10 days, daily LDASA (150 mg) or
placebo, up to 36 weeks of pregnancy. Women will be followed-up for the duration of the
intervention and the pregnancy outcome will be registered. The findings of this study will
contribute to reduce SARS-CoV-2- related complications in a highly vulnerable group to the
infection.
Phase:
Phase 3
Details
Lead Sponsor:
Barcelona Institute for Global Health
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Hopsital Central de Maputo, Mozambique Hospital del Mar Hospital Universitario de Torrejón,Madrid Hospital Universitario Infanta Leonor