COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes
Purpose
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.
Condition
- Covid19
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
|
Recruiting Locations
More Details
- NCT ID
- NCT04659759
- Status
- Completed
- Sponsor
- Thomas Jefferson University
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