Covid19
Conditions
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
Interventions
OTHERCOVID-19 exposure
COVID-19 exposure during pregnancy
BIOLOGICALCOVID-19 vaccine
Receipt of any COVID-19 vaccine
Sponsors
Nemours
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal COVID-19 serology (IgG and IgM) | 6 weeks post partum | IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19 |
| Maternal/neonatal IgG and IgM concordance | Delivery | IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling |
| Maternal COVID serology time/profile following vaccination | 6 months | Baseline, 1m, 3m, 6m post second vaccine dose |
| Breastmilk Serology | 6months | Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastmilk Serology | Delivery | COVID-19 IgG and IgA in breast milk |
| COVID vaccine in pregnant vs nonpregnant | 6 months | Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine |
| Cytokine | Delivery | Compare maternal COVID (+) and COVID (-) cytokine panel |
| Neonatal cytokine | Delivery | Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery |
| COVID disease vs vaccination immune response | 6 months | Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine |
Countries
United States
Outcome results
None listed