Título:	Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study
Autor(es):	Fernandes, Geraldo Magela 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
ORCID:	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
Afiliação do autor:	University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University Hospital of Brasília, Department of Rheumatology State Health Department of the Federal District University Hospital of Brasília, Department of Rheumatology University Center of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine Central Laboratory of Public Health of the Federal District University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University Hospital of Brasília, Department of Rheumatology University Hospital of Brasília, Department of Rheumatology University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University Hospital of Brasília, Department of Rheumatology University Hospital of Brasília, Department of Rheumatology University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University Hospital of Brasília, Department of Rheumatology University of Brasília, Faculty of Medicine University of Brasília, Faculty of Medicine University Hospital of Brasília, Department of Rheumatology University of Brasília, Faculty of Medicine
Assunto:	SARS-CoV-2 Desenvolvimento infantil Desenvolvimento embrionário e fetal Gravidez
Data de publicação:	20-Abr-2021
Referência:	FERNANDES, Geraldo Magela et. al. Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial): protocol for a multicenter, prospective cohort study. JMIR Res Protoc., [s.l.], v. 10, n. 4, e26477, 2021. DOI: https://doi.org/10.2196%2F26477. Disponível em: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059788/. Acesso em: 10 out. 2023.
Abstract:	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.
Unidade Acadêmica:	Faculdade de Medicina (FMD) Faculdade UnB Ceilândia (FCE)
Licença:	This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
DOI:	https://doi.org/10.2196%2F26477
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