NCT05197621

The Impact of COVID-19 on Maternal and Neonatal Outcomes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 14 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection. The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.

Conditions

• COVID-19
• Pregnancy; Infection

Interventions

Type	Name	Description
BIOLOGICAL	mRNA COVID-19 vaccine (Pfizer or Moderna)	mRNA vaccine received at any time during pregnancy course

Timeline

• Start date: 2020-04-13
• Primary completion: 2027-05-05
• Completion: 2028-05-05
• First posted: 2022-01-19
• Last updated: 2025-05-09

Locations

1 site across 1 country: United States