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Observational Maternal COVID-19 Vaccination Study

NCT04826640 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 146

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

OTHER

Observational

Observational

Sponsors & Collaborators

Principal Investigators

  • Geeta K Swamy, MD · Duke University

  • Karen R Broder, MD · Centers for Disease Control and Prevention

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2023-11-13
Completion
2023-11-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04826640 on ClinicalTrials.gov