The Impact of COVID-19 on Maternal and Neonatal Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mRNA COVID-19 vaccine (Pfizer or Moderna).
- Who it may be relevant to
- Registry conditions: COVID-19, Pregnancy; Infection. Basic parameters: 14 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological mRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course
Primary outcome measures
- 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]
Secondary outcome measures (3)
- To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people [Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection]
- To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people [Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection]
- To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people [Time frame: Testing will be performed from the time of study enrollment up to one year after sample collection]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT05197621 · IRB00246472