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

Thomas Jefferson University

Status: Completed

Conditions: Covid19

Treatments: Other: COVID-19 exposure; Biological: COVID-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04659759

20F.1043

Details and patient eligibility

About

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.

Full 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

Enrollment: 105 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

105 participants in 4 patient groups

COVID-19 Positive

Description:

Patients diagnosed with COVID-19 during pregnancy or while breastfeeding

Treatment:

Other: COVID-19 exposure

COVID-19 vaccine

Description:

Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding

Treatment:

Biological: COVID-19 vaccine

Controls

Description:

Reproductive age women exposed to COVID-19 vaccine

Pregnant Control

Description:

Pregnant women who delivered at TJUH, COVID negative