Clinical Trials Directory

Trials / Completed

CompletedNCT04659759

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
105 (actual)
Sponsor
Thomas Jefferson University · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

Summary

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

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

Conditions

Interventions

TypeNameDescription
OTHERCOVID-19 exposureCOVID-19 exposure during pregnancy
BIOLOGICALCOVID-19 vaccineReceipt of any COVID-19 vaccine

Timeline

Start date
2020-11-17
Primary completion
2025-08-30
Completion
2025-08-30
First posted
2020-12-09
Last updated
2025-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04659759. Inclusion in this directory is not an endorsement.