Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection (PROUDEST Trial): Protocol for a
Geraldo Magela Fernandes1, Felipe Motta1, Lizandra Moura Paravidine Sasaki1
1Faculty of Medicine, University of Brasília, Brasília - DF, Brazil.
JMIR Research Protocols
|April 1, 2021
Summary
The PROUDEST study investigates how SARS-CoV-2 infection in pregnant women impacts maternal and infant health. Findings will guide care for mothers and children affected by COVID-19.
Area of Science:
- Obstetrics and Gynecology
- Pediatrics
- Infectious Diseases
Background:
- Growing evidence links SARS-CoV-2 infection during pregnancy to adverse maternal-fetal outcomes.
- Potential long-term developmental implications for children exposed to SARS-CoV-2 in utero are a concern.
Purpose of the Study:
- To elucidate the repercussions of COVID-19 on the global health of mothers and their children.
- To understand the effects of SARS-CoV-2 on pregnancy, childbirth, and infant development.
Main Methods:
- The PROUDEST (Pregnancy Outcomes and Child Development Effects of SARS-CoV-2 Infection Study) is a multicenter, prospective cohort study.
- It includes two substudies: PREGNANT (maternal assessment) and BORN (offspring follow-up to age 5).
- Compares SARS-CoV-2-exposed pregnant women (n=300) and their offspring to unexposed controls (n=300 each).
Main Results:
- Recruitment began July 2020; as of January 2021, 260 infected pregnant women and 160 newborns were enrolled.
- Data analysis is pending completion of data collection.
Conclusions:
- The study will provide comprehensive data on SARS-CoV-2 effects during pregnancy and infancy.
- Findings are expected to inform clinical decisions and public health policies for COVID-19-affected mothers and children.
Keywords:
COVID-19SARS-CoV-2babychildrencohortdevelopmentfetusimplicationneonateoutcomepregnancyprospectivewomenMore Related Videos
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