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. 2021 Apr 20;10(4):e26477.
doi: 10.2196/26477.

Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection (PROUDEST Trial): Protocol for a Multicenter, Prospective Cohort Study

Geraldo Magela Fernandes #  1 , Felipe Motta #  1 , Lizandra Moura Paravidine Sasaki #  1 , Ângelo Pereira Da Silva  2 , Andreza Monforte Miranda  3 , Aleida Oliveira De Carvalho  2 , Ana Paula Monteiro Gomides  4 , Alexandre Anderson De Sousa Munhoz Soares  1 , Agenor De Castro Moreira Dos Santos Jr  5 , Caroline De Oliveira Alves  1 , Ciro Martins Gomes  1 , Clara Correia De Siracusa  1 , David Alves De Araújo Jr  2 , Dayde Lane Mendonça-Silva  2 , José Alfredo Lacerda De Jesus  1 , Karina Nascimento Costa  1 , Maria Eduarda Canellas De Castro  2 , Patricia Shu Kurizky  2 , Paulo Sérgio França  1 , Rosana Tristão  1 , Yacara Ribeiro Pereira  2 , Luiz Claudio Gonçalves De Castro  1 , Alberto Moreno Zaconeta  1 , Cleandro Pires De Albuquerque  2 , Licia Maria Henrique Da Mota  1
Affiliations

Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection (PROUDEST Trial): Protocol for a Multicenter, Prospective Cohort Study

Geraldo Magela Fernandes et al. JMIR Res Protoc. .

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 SARS-CoV-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 COVID-19 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.

Trial registration: Brazilian Register of Clinical Trials RBR65QXS2; https://ensaiosclinicos.gov.br/rg/RBR-65qxs2.

International registered report identifier (irrid): DERR1-10.2196/26477.

Keywords: COVID-19; SARS-CoV-2; baby; children; cohort; development; fetus; implication; neonate; outcome; pregnancy; prospective; women.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection Study follow-up flowchart.
Figure 2
Figure 2
PROUDEST study design. CNS: central nervous system; MRI: magnetic resonance imaging; PROUDEST: Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection Study.
See this image and copyright information in PMC

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