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The Impact of COVID-19 on Maternal and Neonatal Outcomes

Who can join

Ages 14 to 55 · Women · Healthy volunteers welcome

Inclusion Criteria for Vaccine Arm:

* All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy.

Exclusion Criteria:

* Prior COVID-19 infection.

Inclusion Criteria for Sample Collection Arm:

* All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment.
* Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.

Exclusion Criteria:

* None

About the study

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.

What is being tested

• mRNA COVID-19 vaccine (Pfizer or Moderna) (biological)

Sponsor: Johns Hopkins University · Participants: 300 · Started: Apr 13, 2020

Contact the study team

• William C Golden, MD · Phone: 410-955-4588

Official record on ClinicalTrials.gov — NCT05197621

Locations in the U.S.

Conditions

• Post-COVID Conditions (Long COVID)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.