The Impact of COVID-19 on Maternal and Neonatal Outcomes

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05197621
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • mRNA COVID-19 vaccine (Pfizer or Moderna) — BIOLOGICAL
    mRNA vaccine received at any time during pregnancy course

Study Details

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.

Key Dates

Start date
Apr 13, 2020
Status verified
May 2026
Primary completion
May 5, 2027
Completion
May 5, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Vaccine Arm
    Pregnant women who are planning to receive an mRNA COVID vaccine (Pfizer of Moderna), and/or a third booster vaccine, who consent to maternal blood collection before receipt of the vaccine and at 6 time points after receiving the vaccine and/or booster.
  • Arm: Sample Collection at Delivery Arm
    Pregnant patients who have tested positive for COVID during their pregnancy or have a positive COVID test at the time of admission to Labor \& Delivery, who consent to collection of maternal blood, cord blood, placenta, and breast milk samples, as well as neonatal blood and stool samples. Patients testing negative for COVID at the time of admission to Labor \& Delivery can be enrolled in the study as controls.

Primary Outcome Measure

Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy [ Time Frame: Testing will be performed from the time of study enrollment up to one year after sample collection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
William C Golden, M.D..
[email protected]
410-955-4588
Kimberly Jones-Beatty, DNP, CNM
[email protected]
Sabra Klein, PhD (SUB_INVESTIGATOR)
Andrew Pekosz, PhD (SUB_INVESTIGATOR)
Andrea Cox, MD, PhD (SUB_INVESTIGATOR)
Heba Mostafa, PhD (SUB_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Johns Hopkins Hospital· Baltimore, MD

Related Studies