COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes

Conditions
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Covid19

Intervention / Treatment
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* Other: COVID-19 exposure
* Biological: COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Positive<br>Patients diagnosed with COVID-19 during pregnancy or while breastfeeding | Other: COVID-19 exposure<br>* COVID-19 exposure during pregnancy<br>|
| COVID-19 vaccine<br>Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding | Biological: COVID-19 vaccine<br>* Receipt of any COVID-19 vaccine<br>|
| Controls<br>Reproductive age women exposed to COVID-19 vaccine | |
| Pregnant Control<br>Pregnant women who delivered at TJUH, COVID negative | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |