Status:
RECRUITING
The Impact of COVID-19 on Maternal and Neonatal Outcomes
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Integrated Research Center for Fetal Medicine
Conditions:
COVID-19
Pregnancy; Infection
Eligibility:
FEMALE
14-55 years
Brief Summary
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 5 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05197621
Start Date
April 13 2020
End Date
May 5 2028
Last Update
May 9 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287