Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UnB |
Texto Completo: | 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 |
Resumo: | 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. |
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Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort studySARS-CoV-2Desenvolvimento infantilDesenvolvimento embrionárioGravidezBackground: 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.Faculdade de Medicina (FMD)Faculdade UnB Ceilândia (FCE)University of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity Hospital of Brasília, Department of RheumatologyState Health Department of the Federal DistrictUniversity Hospital of Brasília, Department of RheumatologyUniversity Center of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineCentral Laboratory of Public Health of the Federal DistrictUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity Hospital of Brasília, Department of RheumatologyUniversity Hospital of Brasília, Department of RheumatologyUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity Hospital of Brasília, Department of RheumatologyUniversity Hospital of Brasília, Department of RheumatologyUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity Hospital of Brasília, Department of RheumatologyUniversity of Brasília, Faculty of MedicineUniversity of Brasília, Faculty of MedicineUniversity Hospital of Brasília, Department of RheumatologyUniversity of Brasília, Faculty of MedicineFernandes, Geraldo MagelaMotta, FelipeSasaki, Lizandra Moura ParavidineSilva, Ângelo Pereira daMiranda, Andreza MonforteCarvalho, Aleida Oliveira deGomides, Ana Paulo MonteiroSoares, Alexandre Anderson de Sousa MunhozSantos Junior, Agenor de Castro Moreira dosAlves, Caroline de OliveiraGomes, Ciro MartinsSiracusa, Clara Correia deAraújo Júnior, David Alves deSilva, Dayde Lane Mendonça daJesus, José Alfredo Lacerda deCosta, Karina NascimentoCastro, Maria Eduarda Canellas deKurizky, Patricia ShuFrança, Paulo SérgioTristão, Rosana MariaPereira, Yacara RibeiroCastro, Luiz Claudio Gonçalves deZaconeta, Alberto Carlos MorenoAlbuquerque, Cleandro Pires deMota, Licia Maria Henrique da2023-10-10T18:48:58Z2023-10-10T18:48:58Z2021-04-20info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfFERNANDES, 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.http://repositorio2.unb.br/jspui/handle/10482/46658https://doi.org/10.2196%2F26477https://orcid.org/0000-0002-4347-8886https://orcid.org/0000-0002-6733-8722https://orcid.org/0000-0001-6699-291Xhttps://orcid.org/0000-0003-2583-9921https://orcid.org/0000-0003-0298-6929https://orcid.org/0000-0002-8382-4333https://orcid.org/0000-0003-2884-2210https://orcid.org/0000-0003-4716-9543https://orcid.org/0000-0001-8485-2603https://orcid.org/0000-0002-9222-5666https://orcid.org/0000-0002-3069-6884https://orcid.org/0000-0001-9149-957Xhttps://orcid.org/0000-0001-7251-0331https://orcid.org/0000-0001-5653-7411https://orcid.org/0000-0003-3203-4806https://orcid.org/0000-0002-3095-971Xhttps://orcid.org/0000-0001-8727-8328https://orcid.org/0000-0002-5759-2727https://orcid.org/0000-0001-8492-1605https://orcid.org/0000-0002-1751-8506https://orcid.org/0000-0002-5371-5486https://orcid.org/0000-0002-9166-1837https://orcid.org/0000-0001-6440-4395https://orcid.org/0000-0002-9245-7504https://orcid.org/0000-0002-8182-5121engThis 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.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da UnBinstname:Universidade de Brasília (UnB)instacron:UNB2024-07-16T14:04:47Zoai:repositorio.unb.br:10482/46658Repositório InstitucionalPUBhttps://repositorio.unb.br/oai/requestrepositorio@unb.bropendoar:2024-07-16T14:04:47Repositório Institucional da UnB - Universidade de Brasília (UnB)false |
dc.title.none.fl_str_mv |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
title |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
spellingShingle |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study Fernandes, Geraldo Magela SARS-CoV-2 Desenvolvimento infantil Desenvolvimento embrionário Gravidez |
title_short |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
title_full |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
title_fullStr |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
title_full_unstemmed |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
title_sort |
Pregnancy outcomes and child development effects of SARS-CoV-2 Infection (PROUDEST Trial) : protocol for a multicenter, prospective cohort study |
author |
Fernandes, Geraldo Magela |
author_facet |
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 |
author_role |
author |
author2 |
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 |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
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 |
dc.contributor.author.fl_str_mv |
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 |
dc.subject.por.fl_str_mv |
SARS-CoV-2 Desenvolvimento infantil Desenvolvimento embrionário Gravidez |
topic |
SARS-CoV-2 Desenvolvimento infantil Desenvolvimento embrionário Gravidez |
description |
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. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-04-20 2023-10-10T18:48:58Z 2023-10-10T18:48:58Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
dc.identifier.uri.fl_str_mv |
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. 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 |
identifier_str_mv |
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. |
url |
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