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.
Study Type
OBSERVATIONAL
Enrollment
146
Observational
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Boston Medical Center
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Adverse pregnancy outcomes in pregnant women vaccinated with COVID-19 vaccine
As measured by the proportion of women experiencing one of the following: Adverse birth outcome is a composite of occurrence of at least one of the following: preterm birth, spontaneous abortion, fetal death, or neonatal death.
Time frame: 12 months
Preterm birth after COVID-19 vaccination
As measured by proportions of preterm birth after COVID-19 vaccination
Time frame: 12 months
Combined fetal and neonatal death after COVID-19 vaccination
As measured by proportions of combined fetal and neonatal death after COVID-19 vaccination
Time frame: 12 months
Spontaneous abortion after COVID-19 vaccination
As measured by proportions of spontaneous abortion after COVID-19 vaccination
Time frame: 12 months
Pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination
As measured by proportions of pregnant women with moderate/severe solicited reactogenicity events (local and systemic) within 7 days after COVID-19 vaccination
Time frame: 7 days
Women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination
As measured by proportion of women with ≥ 1 severe local and/or systemic reactogenicity event after COVID-19 vaccination
Time frame: 3 months
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