The Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection Study (PROUDEST): A Multicenter Prospective Cohort Study Protocol (Preprint)
Authors: Fernandes Geraldo Magela , Sasaki Lizandra Moura Paravidine , Motta Felipe , Silva Ângelo Pereira Da , Miranda Andreza Monforte , Gomides Ana Paula , Soares Alexandre Anderson De Sousa , Carvalho Aleida Oliveira De , Alves Caroline De Oliveira , Santos Jr Agenor De Castro Moreira Dos , Gomes Ciro Martins , Araújo Jr David Alves De , Silva Dayde Lane Mendonça Da , Jesus José Alfredo Lacerda De , Costa Karina Nascimento , Castro Maria Eduarda Canellas De , Kurisky 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 
Published: October 2020

BACKGROUND

A growing body of evidence suggests that infection by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) during pregnancy may affect maternal-fetal outcomes, with possible implications for the long-term development of exposed children

OBJECTIVE

The PRegnancy OUtcomes and child Development Effects of SARS-CoV-2 infection STudy (PROUDEST) is a multicenter prospective study designed to understand the repercussions of COVID-19 to mother-child global health.

METHODS

The PROUDEST trial comprises two prospective sequential substudies. The PREGNANT substudy will assess the effects of SARS-CoV-2 infection on pregnancy, childbirth and puerperium clinically and from a mechanistic standpoint to understand the inflammatory and immunological phenomena underlying COVID-19 in relation to pregnancy. Pregnant women aged 18 to 40 years with laboratory-proven exposure 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 assessing the offspring of women who entered 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 five 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 from nonexposed mothers.

RESULTS

The recruitment has begun in July, 2020 and until September, 2020, 115 pregnant women infected with SARS-CoV-2 during pregnancy and 80 newborns were included. Data analysis is scheduled to start after all inclusion data have been collected.

CONCLUSIONS

Upon completion of the study, we expect to have obtained comprehensive data to provide a better understanding of the effects of SARS-CoV-2 and its inflammatory and immunological processes on pregnancy, puerperium and infancy. Our findings will inform clinical decisions regarding the care of exposed mothers and children and support the development of evidence-based public health policies.

CLINICALTRIAL

The PROUDEST study was registered on the Brazilian Register of Clinical Trials website (https://www. http://www.ensaiosclinicos.gov.br), ID RBR-65qxs2, on June 13th, 2020, where Brazilian clinical trials are exclusively registered.