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LEARNER - A prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with sickle cell disease when initiated at the first trimester versus the second trimester of the gestational period: study protocol
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Orientador(es)
Resumo(s)
Background: Pregnancy in women with Sickle Cell Disease (SCD) is associated with an increased risk of severe complications, such as eclampsia, pre-eclampsia, maternal death, intrauterine growth restrictions, perinatal mortality, and low birth weight. Since 50% of these patients are now living to reproductive age, the management of SCD during pregnancy has become pertinent. Searching for prophylactic and affordable measures for early prevention of these complications is urgently needed. Methods: A daily low dosage of Aspirin is widely used during pregnancy to prevent pre-eclampsia and other vascular disorders. But the lack of evidence of effectiveness in pregnant women with SCD leads to the need to develop clinical trials with this population. In this prospective controlled study, we intend to evaluate the effects of daily low-dose aspirin in pregnant women with SCD, testing the hypothesis that if daily use of low-dose aspirin is initiated early in pregnancy (between 6 and 13 weeks of gestation) versus in the second trimester (between 14 and 27 weeks of gestation), it reduces the incidence of preterm birth mother mortality, and miscarriage. Discussion: The expected impact of the proposed project includes reducing maternal and child mortality due to SCD and reducing the morbidity in pregnancy and delivery. Trial registration: This study was registered at ClinicalTrials.gov. Trial registration: NCT06417411, on May 16th, 2024.
Descrição
The present project has the support of Calouste Gulbenkian Foundation and La Caixa Foundation Collaboration (We’Search). This work is also partially funded by FCT/MCTES UIDB/05608/2020, UIDP/05608/2020, and by project reference 2023.00426.BD.
Palavras-chave
Sickle cell disease Aspirin Preterm birth Preeclampsia Maternal mortality Fetal mortality Intrauterine growth restriction Angola FCT_UIDB/05608/2020 FCT_UIDP/05608/2020 2023.00426.BD
Contexto Educativo
Citação
Brito M, Ginete C, Gomes T, Pitangueira H, Mendes M, Furtado A, et al. LEARNER – A prospective, randomized controlled study to evaluate the effects of daily low dose aspirin in pregnant women with sickle cell disease when initiated at the first trimester versus the second trimester of the gestational period: study protocol. Contemp Clin Trials Commun. 2026;51:101649.
Editora
Elsevier BV