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The Impact of COVID-19 on Maternal and Neonatal Outcomes

NCT05197621 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

mRNA COVID-19 vaccine (Pfizer or Moderna)

mRNA vaccine received at any time during pregnancy course

Sponsors & Collaborators

Principal Investigators

  • William C Golden, MD · Johns Hopkins University

Eligibility

Min Age
14 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2027-05-05
Completion
2028-05-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197621 on ClinicalTrials.gov