COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- COVID-19 exposure
- Conditions
- Covid19
- Sponsor
- Thomas Jefferson University
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Maternal COVID serology time/profile following vaccination
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.
Detailed Description
This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of COVID-19 in pregnancy or within 6 months post partum
- •Planned delivery at Thomas Jefferson University Hospital
Exclusion Criteria
- •Declines routine COVID testing on admission
- •In active labor/pain/otherwise unable to provide consent
Arms & Interventions
COVID-19 Positive
Patients diagnosed with COVID-19 during pregnancy or while breastfeeding
Intervention: COVID-19 exposure
COVID-19 vaccine
Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding
Intervention: COVID-19 vaccine
Outcomes
Primary Outcomes
Maternal COVID serology time/profile following vaccination
Time Frame: 6 months
Baseline, 1m, 3m, 6m post second vaccine dose
Maternal/neonatal IgG and IgM concordance
Time Frame: Delivery
IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
Breastmilk Serology
Time Frame: 6months
Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women
Maternal COVID-19 serology (IgG and IgM)
Time Frame: 6 weeks post partum
IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19
Secondary Outcomes
- Breastmilk Serology(6 weeks post partum)
- Neonatal cytokine(Delivery)
- Cytokine(Delivery)
- COVID disease vs vaccination immune response(6 months)
- COVID vaccine in pregnant vs nonpregnant(6 months)