The Impact of COVID-19 on Maternal and Neonatal Outcomes

Johns Hopkins University

Status: Enrolling

Conditions: COVID-19; Pregnancy; Infection

Treatments: Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)

Study type: Observational

Funder types: Other

Identifiers

NCT05197621

IRB00246472

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 14 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 2 patient groups

Vaccine Arm

Description:

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.

Treatment:

Biological: mRNA COVID-19 vaccine (Pfizer or Moderna)

Sample Collection at Delivery Arm

Description:

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.