Fernandes Geraldo Magela, Motta Felipe, Sasaki Lizandra Moura Paravidine, Silva Ângelo Pereira Da, Miranda Andreza Monforte, Carvalho Aleida Oliveira De, Gomides Ana Paula Monteiro, Soares Alexandre Anderson De Sousa Munhoz, Santos Agenor De Castro Moreira Dos, Alves Caroline De Oliveira, Gomes Ciro Martins, Siracusa Clara Correia De, Araújo David Alves De, Mendonça-Silva Dayde Lane, Jesus José Alfredo Lacerda De, Costa Karina Nascimento, Castro Maria Eduarda Canellas De, Kurizky Patricia Shu, França Paulo Sérgio, Tristão Rosana, Pereira Yacara Ribeiro, Castro Luiz Claudio Gonçalves De, Zaconeta Alberto Moreno, Albuquerque Cleandro Pires De, Mota Licia Maria Henrique Da
Faculty of Medicine, University of Brasília, Brasília - DF, Brazil.
Department of Rheumatology, University Hospital of Brasília, Brasília, Brazil.
JMIR Res Protoc. 2021 Apr 20;10(4):e26477. doi: 10.2196/26477.
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 SARS-CoV-2-exposed children.
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 COVID-19 for the global health of mothers and their children.
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.
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.
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.
Brazilian Register of Clinical Trials RBR65QXS2; https://ensaiosclinicos.gov.br/rg/RBR-65qxs2.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26477.
越来越多的证据表明，孕期感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）可能会影响母婴结局，并可能对接触过SARS-CoV-2的儿童的长期发育产生影响。
“最自豪”研究（SARS-CoV-2感染对妊娠结局和儿童发育的影响研究）是一项多中心前瞻性队列研究，旨在阐明2019冠状病毒病（COVID-19）对母亲及其子女全球健康的影响。
“最自豪”试验包括2项前瞻性、连续性子研究。“孕妇”子研究将从机制角度临床评估SARS-CoV-2感染对妊娠、分娩和产褥期的影响，以阐明COVID-19潜在的与妊娠相关的炎症和免疫现象。将18至40岁经实验室检测证实接触过SARS-CoV-2的孕妇（A组；n = 300）与无孕期病毒接触实验室证据的对照对象（B组；n = 300）进行比较。孕期接触过其他感染的对象将被排除。“出生”子研究是一项长期随访研究，将评估参与前一项子研究的女性的后代。它将描述孕期接触SARS-CoV-2对儿童从出生到5岁的生长、神经发育和代谢的影响。它包括两个比较组；A组（接触组；n = 300）包括SARS-CoV-2感染孕期出生的儿童，B组（对照组；n = 300）包括未接触过病毒的母亲所生的儿童。
招募工作于2020年7月开始，截至2021年1月，该研究已纳入260名孕期感染SARS-CoV-2的孕妇和160名新生儿。数据分析计划在所有数据收集完成后开始。
研究完成后，我们预计将获得全面的数据，从而更好地了解SARS-CoV-2感染以及相关炎症和免疫过程对妊娠、产褥期和婴儿期的影响。我们的研究结果将为有关接触SARS-CoV-2的母亲和儿童护理的临床决策提供依据，并支持制定基于证据的公共卫生政策。
巴西临床试验注册中心RBR65QXS2；https://ensaiosclinicos.gov.br/rg/RBR-65qxs2。
国际注册报告识别码（IRRID）：DERR1-10.2196/26477。
