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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

2026-06Artigo científico Acesso aberto
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datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorBrito, Miguel
dc.contributor.authorGinete, Catarina
dc.contributor.authorGomes, Tatiana
dc.contributor.authorPitangueira, Helena
dc.contributor.authorMendes, Manuela
dc.contributor.authorFurtado, Ana
dc.contributor.authorAlves, Ligia
dc.contributor.authorSimão, Fernanda
dc.contributor.authorGonçalves, Mauer
dc.contributor.authorMorais, Joana
dc.date.accessioned2026-05-26T11:28:43Z
dc.date.available2026-05-26T11:28:43Z
dc.date.issued2026-06
dc.descriptionThe 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.
dc.description.abstractBackground: 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.eng
dc.description.sponsorshipThe 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 (https://doi.org/10.54499/UIDB/05608/2020), UIDP/05608/2020 (https://doi.org/10.54499/UIDP/05608/2020), and by project reference 2023.00426.BD (https://doi.org/10.54499/2023.00426.BD).
dc.identifier.citationBrito 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.
dc.identifier.doi10.1016/j.conctc.2026.101649
dc.identifier.issn2451-8654
dc.identifier.urihttp://hdl.handle.net/10400.21/22897
dc.language.isoeng
dc.peerreviewedyes
dc.publisherElsevier BV
dc.relation.hasversionhttps://www.sciencedirect.com/science/article/pii/S2451865426000566
dc.relation.ispartofContemporary Clinical Trials Communications
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectSickle cell disease
dc.subjectAspirin
dc.subjectPreterm birth
dc.subjectPreeclampsia
dc.subjectMaternal mortality
dc.subjectFetal mortality
dc.subjectIntrauterine growth restriction
dc.subjectAngola
dc.subjectFCT_UIDB/05608/2020
dc.subjectFCT_UIDP/05608/2020
dc.subject2023.00426.BD
dc.titleLEARNER - 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 protocoleng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.startPage101649
oaire.citation.titleContemporary Clinical Trials Communications
oaire.citation.volume51
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameBrito
person.familyNameHonrado Ginete
person.givenNameMiguel
person.givenNameAna Catarina
person.identifier.ciencia-id231F-F341-7E93
person.identifier.ciencia-id8715-F62E-1E0F
person.identifier.orcid0000-0001-6394-658X
person.identifier.orcid0000-0002-2334-782X
person.identifier.ridA-7970-2016
person.identifier.scopus-author-id35224551000
relation.isAuthorOfPublication4252d8e0-800c-4d67-8b13-0b711d860669
relation.isAuthorOfPublicationdfb2fbba-17ff-42fb-905a-fcfc8f326e1c
relation.isAuthorOfPublication.latestForDiscovery4252d8e0-800c-4d67-8b13-0b711d860669

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