Actively Recruiting
The Impact of COVID-19 on Maternal and Neonatal Outcomes
Led by Johns Hopkins University · Updated on 2026-05-11
300
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
I
Integrated Research Center for Fetal Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Impact of COVID-19 on Maternal and Neonatal Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women receiving prenatal care at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center planning to receive an mRNA COVID-19 vaccine or booster during pregnancy
- Pregnant women admitted for delivery at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
- Pregnant women with a positive COVID-19 test during pregnancy or at admission to Labor & Delivery
- Newborns of enrolled mothers at birth
You will not qualify if you...
- Prior COVID-19 infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
W
William C Golden, MD
CONTACT
K
Kimberly Jones-Beatty, DNP, CNM
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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