The Impact of COVID-19 on Maternal and Neonatal Outcomes
1 other identifier
observational
300
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 13, 2020
CompletedFirst Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 5, 2028
May 9, 2025
May 1, 2025
7.1 years
January 14, 2022
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
Evaluation of biospecimens (maternal \& neonatal blood, cord blood, placenta samples, neonatal stool samples \& breast milk) collected from recently delivered pregnant women and neonates for biomarkers of placental inflammation and early onset neonatal sepsis.
Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary Outcomes (3)
To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
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
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
Testing will be performed from the time of study enrollment up to one year after sample collection
Study Arms (2)
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.
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.
Interventions
mRNA vaccine received at any time during pregnancy course
Eligibility Criteria
All pregnant women, aged 14-55, receiving prenatal care from 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, or, patients who have had a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.
You may qualify if:
- 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.
You may not qualify if:
- Prior COVID-19 infection.
- 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.
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Biospecimen
Maternal blood, maternal breast milk, cord blood, neonatal blood, urine, and stool.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William C Golden, MD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 19, 2022
Study Start
April 13, 2020
Primary Completion (Estimated)
May 5, 2027
Study Completion (Estimated)
May 5, 2028
Last Updated
May 9, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share