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Implementation challenges of the learner clinical trial in pregnant women with sickle cell disease in Angola

datacite.subject.sdg03:Saúde de Qualidade
dc.contributor.authorGinete, Catarina
dc.contributor.authorBrito, Miguel
dc.contributor.authorGomes, Tatiana
dc.contributor.authorPintangueira, 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.accessioned2025-12-23T09:08:29Z
dc.date.available2025-12-23T09:08:29Z
dc.date.issued2025-12
dc.descriptionThe present project has the support of Calouste Gulbenkian Foundation and La Caixa Foundation Collaboration (We’Search).
dc.description.abstractSickle Cell Disease (SCD), a severe inherited blood disorder, poses significant risks during pregnancy, particularly in regions like Sub-Saharan Africa, where its prevalence is high. Pregnancy often intensifies the complications associated with SCD, including severe anemia and vaso-occlusive crises, while also elevating the risk of obstetric complications such as pre-eclampsia, eclampsia, intrauterine growth restriction, low birth weight, and maternal or fetal death. These heightened risks underscore the critical importance of close medical surveillance throughout pregnancy. Moreover, there is an urgent need to identify affordable, preventive strategies, especially in low- and middle-income countries where health systems are often overburdened, and resources are limited. Considering these critical needs, clinical research initiatives like the LEARNER clinical study (NCT06417411) are crucial for developing and evaluating interventions that could improve outcomes for pregnant women with SCD in Sub-Saharan Africa. However, conducting such research in countries like Angola is fraught with complex implementation challenges. These include resource limitations in both the research sites and the patient population, and societal norms related to prenatal visits. The use of daily low-dose aspirin is considered safe in pregnant women with SCD and is recommended after 12 weeks of gestational age by the British Society of Hematology for those at severe risk of preeclampsia. The LEARNER Study aims to evaluate the effects of daily low-dose aspirin in SCD pregnancy, comparing its impact on severe outcomes if this prophylactic and affordable medication is started in the first or the second trimester. This study aims to recruit 450 pregnant women with a confirmed SCD diagnosis in multiple maternity and infant hospitals in Luanda, Angola. Consenting patients will be assigned to either the first (weeks 6-13) or second (weeks 14-27) trimester groups, based on their gestational age, as confirmed by ultrasound. Participants will start daily low-dose aspirin and will do regular follow-up appointments till 6 weeks postpartum. Aspirin will be interrupted at week 36, delivery time, or earlier if decided by the clinical team.eng
dc.identifier.citationGinete C, Brito M, Gomes T, Pintangueira H, Mendes M, Furtado A, et al. Implementation challenges of the learner clinical trial in pregnant women with sickle cell disease in Angola. In: 67th ASH Annual Meeting, New Orleans, Louisiana (USA), December 6-9, 2025.
dc.identifier.urihttp://hdl.handle.net/10400.21/22399
dc.language.isoeng
dc.peerreviewedyes
dc.relation.hasversionhttps://submit.hematology.org/program/presentation/677344
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subjectWomens health
dc.subjectClinical trial
dc.subjectStudy population
dc.subjectHealth outcomes research
dc.subjectPregnancy
dc.subjectSickle cell disease
dc.subjectHemoglobinopathy
dc.subjectTreatment considerations
dc.subjectClinical research
dc.subjectReal-world evidence
dc.subjectNon-biological therapy
dc.subjectAngola
dc.titleImplementation challenges of the learner clinical trial in pregnant women with sickle cell disease in Angolaeng
dc.typeconference poster
dspace.entity.typePublication
oaire.citation.conferenceDate2025-12
oaire.citation.conferencePlaceNew Orleans, Estados Unidos
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameHonrado Ginete
person.familyNameBrito
person.givenNameAna Catarina
person.givenNameMiguel
person.identifier.ciencia-id8715-F62E-1E0F
person.identifier.ciencia-id231F-F341-7E93
person.identifier.orcid0000-0002-2334-782X
person.identifier.orcid0000-0001-6394-658X
person.identifier.ridA-7970-2016
person.identifier.scopus-author-id35224551000
relation.isAuthorOfPublicationdfb2fbba-17ff-42fb-905a-fcfc8f326e1c
relation.isAuthorOfPublication4252d8e0-800c-4d67-8b13-0b711d860669
relation.isAuthorOfPublication.latestForDiscoverydfb2fbba-17ff-42fb-905a-fcfc8f326e1c

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