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| Name | Class |
|---|---|
| Nemours | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 Positive | Patients diagnosed with COVID-19 during pregnancy or while breastfeeding |
| |
| COVID-19 vaccine | Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding |
| |
| Controls | Reproductive age women exposed to COVID-19 vaccine | ||
| Pregnant Control | Pregnant women who delivered at TJUH, COVID negative |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 exposure | Other | COVID-19 exposure during pregnancy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal COVID-19 serology (IgG and IgM) | IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19 | 6 weeks post partum |
| Maternal/neonatal IgG and IgM concordance | IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling | Delivery |
| Maternal COVID serology time/profile following vaccination | Baseline, 1m, 3m, 6m post second vaccine dose | 6 months |
| Breastmilk Serology | Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women | 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Breastmilk Serology | COVID-19 IgG and IgA in breast milk | Delivery |
| Breastmilk Serology | COVID-19 IgG and IgA in breastmilk | 6 weeks post partum |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Maternal serum/plasma
Cord blood serum/plasm
Breastmilk o SARS-CoV-2 serology
| COVID-19 vaccine |
| Biological |
Receipt of any COVID-19 vaccine |
|
| Cytokine | Compare maternal COVID (+) and COVID (-) cytokine panel | Delivery |
| Neonatal cytokine | Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery | Delivery |
| COVID disease vs vaccination immune response | Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine | 6 months |
| COVID vaccine in pregnant vs nonpregnant | Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine | 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |