The Impact of COVID-19 on Maternal and Neonatal Outcomes
NCT ID: NCT05197621
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2020-04-13
2028-05-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
mRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course
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.
No interventions assigned to this group
Interventions
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mRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
14 Years
55 Years
FEMALE
Yes
Sponsors
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Integrated Research Center for Fetal Medicine
UNKNOWN
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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William C Golden, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00246472
Identifier Type: -
Identifier Source: org_study_id
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