The Impact of COVID-19 on Maternal and Neonatal Outcomes

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Testing will be performed from the time of study enrollment up to one year after sample collection]

Критерии участия

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.

Критерии исключения

• 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.

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Johns Hopkins Hospital — Baltimore

Идентификаторы

NCT: NCT05197621 · IRB00246472

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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