The Impact of COVID-19 on Maternal and Neonatal Outcomes

Last updated: May 6, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

mRNA COVID-19 vaccine (Pfizer or Moderna)

Clinical Study ID

NCT05197621
IRB00246472
  • Ages 14-55
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria for Vaccine Arm:

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

Exclusion

Exclusion Criteria:

  • Prior COVID-19 infection.

Inclusion Criteria for Sample Collection Arm:

  • All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins BayviewMedical Center for delivery and their newborn (at birth), will be considered forenrollment.

  • Pregnant patients with a positive COVID-19 test during their pregnancy or at thetime of admission to Labor & Delivery.

Exclusion Criteria:

  • None

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: mRNA COVID-19 vaccine (Pfizer or Moderna)
Phase:
Study Start date:
April 13, 2020
Estimated Completion Date:
May 05, 2028

Connect with a study center

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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