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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: COVID-19 exposure; Biological: COVID-19 vaccine

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

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Nemours

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; COVID-19 Vaccines
• Other Study ID Numbers: 20F.1043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No