SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse maternal and perinatal outcomes. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status, leading to a higher risk of 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 LDASA in preventing complications in SARS-CoV-2- infected pregnant women. To reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection, we will carry out this randomized, double-blind, placebo-controlled multicentre trial in 400 SARS-CoV-2-infected pregnant women. The study main objective is to evaluate the efficacy and safety of LDASA administered up to 36 weeks of gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal and perinatal outcomes. Pregnant women tested positive up to 32 weeks of gestation with a SARS-CoV-2 rapid antigen or PCR test and agreeing to participate, will be randomised 1:1 to receive daily LDASA (125 mg) or placebo up to 36 weeks of gestation and be followed-up until delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
38
In case of being positive for SARS-CoV-2 PCR or antigen test, she will be randomised 1:1 to receive daily LDASA (125 mg) or placebo, up to 36 weeks of pregnancy.
Placebo
Universidade Eduardo Mondlane
Maputo, Mozambique
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Sant Joan de Déu
Barcelona, Catalonia, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Rate of composite adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age.
Time frame: up to 37 weeks
Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
maternal
Time frame: up to 37 weeks
Incidence of COVID-19-related admissions
maternal
Time frame: up to 37 weeks
Incidence of all-cause admissions
maternal
Time frame: up to 37 weeks
Incidence of all-cause outpatient attendances
maternal
Time frame: up to 37 weeks
Mean duration of symptoms-signs of COVID-19
maternal
Time frame: up to 37 weeks
Frequency and severity of adverse events
maternal
Time frame: up to 37 weeks
Incidence of preeclampsia
maternal
Time frame: up to 37 weeks
Incidence of maternal thromboembolic complications and placental abruption
maternal
Time frame: up to 37 weeks
Maternal mortality rate
maternal
Time frame: up to 37 weeks
Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women.
maternal
Time frame: up to 37 weeks
Prevalence of preterm birth (<37 weeks of gestational age)
embryo-foetal/infant
Time frame: up to 37 weeks
Prevalence of small for gestational age
embryo-foetal/infant
Time frame: up to 37 weeks
Prevalence of embryo and foetal losses (miscarriages and stillbirths)
embryo-foetal/infant
Time frame: up to 37 weeks
Frequency of congenital malformations
embryo-foetal/infant
Time frame: up to 37 weeks
Proportion of adverse perinatal outcome
embryo-foetal/infant
Time frame: up to 37 weeks
Neonatal morbidity
embryo-foetal/infant
Time frame: up to 37 weeks
Neonatal mortality rate
embryo-foetal/infant
Time frame: up to 37 weeks
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