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The Impact of COVID-19 on Maternal and Neonatal Outcomes

Johns Hopkins University · with Integrated Research Center for Fetal Medicine · NCT05197621

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 14–55 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
300
US sites recruiting
1
Study start
April 13, 2020
Record last updated
May 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: mRNA COVID-19 vaccine (Pfizer or Moderna)

Conditions: COVID-19; Pregnancy; Infection

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Johns Hopkins Hospital

    Baltimore, MD 21287

    Site contact: William C Golden, M.D.. · 410-955-4588 · cgolden@jhmi.edu

Study contacts (from the official record)

  • William C Golden, MD · 410-955-4588 · cgolden@jhmi.edu
  • Kimberly Jones-Beatty, DNP, CNM · kjone111@jhmi.edu
All pregnancy studies in Maryland →
The Impact of COVID-19 on Maternal and Neonatal Outcomes (NCT05197621) | Bored Studies