Observational Maternal COVID-19 Vaccination Study

Status Completed

Clinical Trial Summary

This is a prospective, observational study. During the study, pregnant women will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and during the 7 days following the second vaccination using either identical web-based or paper diaries, depending on study participant preference. Maternal serum samples will be collected for antibody titers relevant to COVID-19 at time points that include: prior to vaccination, ~29 days post second vaccination, and at delivery. At Duke University, maternal and infant cord blood will be collected at delivery and analyzed for the same antibody titers. At other clinical sites, these delivery samples will only be collected if feasible. Pregnant women will be followed through 90 days postpartum. with comprehensive obstetric and neonatal outcomes obtained from medical record review.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04826640
Study type	Observational
Source	Duke University
Contact
Status	Completed
Phase
Start date	May 24, 2021
Completion date	November 13, 2023

View Details

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