REBRACO/WHO – Rede Brasileira de Estudo sobre COVID-19 em Obstetrícia/WHO - Um estudo de coorte prospectivo para investigação dos resultados maternos, gestacionais e neonatais em mulheres e neonatos infectados pelo SARS-CoV-2

Version 1.0
Nascimento, Maria Laura Costa do; Cecatti, José Guilherme; Souza, Renato Teixeira, 2026, "REBRACO/WHO – Rede Brasileira de Estudo sobre COVID-19 em Obstetrícia/WHO - Um estudo de coorte prospectivo para investigação dos resultados maternos, gestacionais e neonatais em mulheres e neonatos infectados pelo SARS-CoV-2", https://doi.org/10.25824/redu/CKKFYT, Repositório de Dados de Pesquisa da Unicamp , V1
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Description
A finalidade do estudo foi determinar se a infecção pelo SARS-CoV-2 durante a gravidez aumenta o risco de resultados adversos gestacionais, puerperais ou neonatais. Além disso, o estudo pretendia caracterizar o espectro clínico da doença do coronavírus 2019 (COVID-19) em gestantes, com quantificação (se houver) da taxa de transmissão intra-uterina/intra-parto/pós-natal, incidência de RNA detectável do SARS-CoV-2 nos fluidos e tecidos relacionados à gestação, com seguimento dos resultados clínicos em mulheres e seus recém-nascidos até 6 semanas após o nascimento
Subject Medicine, Health and Life Sciences
Keyword COVID-19, Gestação
Related Publication https://www.who.int/publications/i/item/WHO-2019-nCoV-pregnancy-and-neonates-2022.1
Notes Artigo principal ainda não publicado. Projeto multicêntrico internacional, com claras regras para compartilhamento de dados. A fim de proteger a identidade da paciente, qualquer publicação ou apresentação relacionado ao estudo, usará somente os dados agregados resumidos. Os formulários de coleta de dados originais serão armazenados em local de armazenamento fechado, de acordo com os regulamentos nacionais. Um log de identificação será usado, e o log será armazenado em local seguro e trancado dentro do país do estudo. Todos os documentos essenciais serão eletronicamente arquivados e retidos na OMS (Organização Mundial de Saúde) por três anos ou pela mesma duração, exigida pelas leis nacionais e regulamentos dos centros de pesquisa locais. Isto é para permitir a conclusão do estudo, condução e conclusão do processo de curadoria dos dados, e finalizar a publicação e processo de arquivamento. Uma banca editorial e governante será estabelecida com membros do consórcio. Seguindo as diretrizes da CIOMS, uma estrutura de governança para compartilhamento de dados analíticos harmonizados será implementada. Para garantir o compartilhamento de informações com a iniciativa global da OMS, os pesquisadores realizarão, o convite às mulheres participantes para que realizem (ou não) o compartilhamento de seus dados para essa iniciativa. Isso significa que cada mulher será esclarecida sobre essa possibilidade e que seus dados individuais sobre o estudo só serão compartilhados para compor o banco de dados global após seu consentimento/autorização expressa através do termo de consentimento livre e esclarecido e termo de assentimento livre esclarecido, quando pertinente. Portanto, os dados os dados ainda não podem ser disponibilizados por questões de proteção intelectual. Para mais informações, contatar os responsáveis do depósito
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