Observational Maternal COVID-19 Vaccination Study - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the safety and effectiveness of the COVID-19 vaccine in pregnant women.

What we learn from this study may help doctors better understand if there is a difference in side effects or health outcomes after getting different COVID-19
vaccines during pregnancy.

What is the Condition Being Studied?

Pregnant Women and the COVID-19 Vaccine

Who Can Participate in the Study?

Pregnant women 18-45 years old who:
-Intend to get a COVID-19 vaccine at an approved vaccine location
-Are less than 34 weeks pregnant
-Are in general good health
-Are planning to deliver their baby at Duke University Hospital or Duke Regional Hospital

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Get your COVID-19 vaccine through an appointment that you have scheduled based on national and local guidelines
-Either just before or after getting your vaccine, come to the clinic to get set up with materials
-Keep track of your temperature and any side effects (either online or on paper) for 7 days following the vaccine dose(s)
-Complete 2-3 follow-up visits to the clinic to give a blood sample

Study Details

Full Title
A Prospective Observational Study to Evaluate the Safety of COVID-19 Vaccination in Pregnant Women
Principal Investigator
Maternal-Fetal Medicine Specialist
Protocol Number
IRB: PRO00107518
NCT: NCT04826640
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698