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Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study

Furkejuvvon:
Bibliográfalaš dieđut
Váldodahkki: Fernandes, Geraldo Magela
Almmustuhttinbeaivi: 2021
Eará dahkkit: Motta, Felipe, Sasaki, Lizandra Moura Paravidine, Silva, Ângelo Pereira da, Miranda, Andreza Monforte, Carvalho, Aleida Oliveira de, Gomides, Ana Paulo Monteiro, Soares, Alexandre Anderson de Sousa Munhoz, Santos Junior, Agenor de Castro Moreira dos, Alves, Caroline de Oliveira, Gomes, Ciro Martins, Siracusa, Clara Correia de, Araújo Júnior, David Alves de, Silva, Dayde Lane Mendonça da, Jesus, José Alfredo Lacerda de, Costa, Karina Nascimento, Castro, Maria Eduarda Canellas de, Kurizky, Patricia Shu, França, Paulo Sérgio, Tristão, Rosana Maria, Pereira, Yacara Ribeiro, Castro, Luiz Claudio Gonçalves de, Zaconeta, Alberto Carlos Moreno, Albuquerque, Cleandro Pires de, Mota, Licia Maria Henrique da
Materiálatiipa: Article
Giella: eng
Gáldu: Repositório Institucional da UnB
Download full: http://repositorio2.unb.br/jspui/handle/10482/46658
https://doi.org/10.2196%2F26477
https://orcid.org/0000-0002-4347-8886
https://orcid.org/0000-0002-6733-8722
https://orcid.org/0000-0001-6699-291X
https://orcid.org/0000-0003-2583-9921
https://orcid.org/0000-0003-0298-6929
https://orcid.org/0000-0002-8382-4333
https://orcid.org/0000-0003-2884-2210
https://orcid.org/0000-0003-4716-9543
https://orcid.org/0000-0001-8485-2603
https://orcid.org/0000-0002-9222-5666
https://orcid.org/0000-0002-3069-6884
https://orcid.org/0000-0001-9149-957X
https://orcid.org/0000-0001-7251-0331
https://orcid.org/0000-0001-5653-7411
https://orcid.org/0000-0003-3203-4806
https://orcid.org/0000-0002-3095-971X
https://orcid.org/0000-0001-8727-8328
https://orcid.org/0000-0002-5759-2727
https://orcid.org/0000-0001-8492-1605
https://orcid.org/0000-0002-1751-8506
https://orcid.org/0000-0002-5371-5486
https://orcid.org/0000-0002-9166-1837
https://orcid.org/0000-0001-6440-4395
https://orcid.org/0000-0002-9245-7504
https://orcid.org/0000-0002-8182-5121
Čoahkkáigeassu: Background: A growing body of evidence suggests that SARS-COV-2 infection during pregnancy may affect maternal-fetal outcomes and possibly result in implications for the long-term development of SARSCoV-2–exposed children. Objective: The PROUDEST (Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection Study) is a multicenter, prospective cohort study designed to elucidate the repercussions of COVID19 for the global health of mothers and their children. Methods: The PROUDEST trial comprises 2 prospective, sequential substudies. The PREGNANT substudy will clinically assess the effects of SARS-CoV-2 infection on pregnancy, childbirth, and puerperium from a mechanistic standpoint to elucidate the pregnancy-related inflammatory and immunological phenomena underlying COVID-19. Pregnant women aged 18-40 years who have been exposed (proven with laboratory tests) to SARS-CoV-2 (group A; n=300) will be compared to control subjects with no laboratory evidence of in-pregnancy exposure to the virus (group B; n=300). Subjects exposed to other infections during pregnancy will be excluded. The BORN substudy is a long-term follow-up study that will assess the offspring of women who enrolled in the prior substudy. It will describe the effects of SARS-CoV-2 exposure during pregnancy on children’s growth, neurodevelopment, and metabolism from birth up to 5 years of age. It includes two comparison groups; group A (exposed; n=300) comprises children born from SARS-CoV-2– exposed pregnancies, and group B (controls; n=300) comprises children born from nonexposed mothers. Results: Recruitment began in July 2020, and as of January 2021, 260 pregnant women who were infected with SARS-CoV-2 during pregnancy and 160 newborns have been included in the study. Data analysis is scheduled to start after all data are collected. Conclusions: Upon completion of the study, we expect to have comprehensive data that will provide a better understanding of the effects of SARS-CoV-2 infection and related inflammatory and immunological processes on pregnancy, puerperium, and infancy. Our findings will inform clinical decisions regarding the care of SARS-CoV-2–exposed mothers and children and support the development of evidence-based public health policies.

Interneahtta

http://repositorio2.unb.br/jspui/handle/10482/46658
https://doi.org/10.2196%2F26477
https://orcid.org/0000-0002-4347-8886
https://orcid.org/0000-0002-6733-8722
https://orcid.org/0000-0001-6699-291X
https://orcid.org/0000-0003-2583-9921
https://orcid.org/0000-0003-0298-6929
https://orcid.org/0000-0002-8382-4333
https://orcid.org/0000-0003-2884-2210
https://orcid.org/0000-0003-4716-9543
https://orcid.org/0000-0001-8485-2603
https://orcid.org/0000-0002-9222-5666
https://orcid.org/0000-0002-3069-6884
https://orcid.org/0000-0001-9149-957X
https://orcid.org/0000-0001-7251-0331
https://orcid.org/0000-0001-5653-7411
https://orcid.org/0000-0003-3203-4806
https://orcid.org/0000-0002-3095-971X
https://orcid.org/0000-0001-8727-8328
https://orcid.org/0000-0002-5759-2727
https://orcid.org/0000-0001-8492-1605
https://orcid.org/0000-0002-1751-8506
https://orcid.org/0000-0002-5371-5486
https://orcid.org/0000-0002-9166-1837
https://orcid.org/0000-0001-6440-4395
https://orcid.org/0000-0002-9245-7504
https://orcid.org/0000-0002-8182-5121

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