Clinical Trials / Research Studies

Clinical Trials / Research Studies

COVID-19 Vaccine Study For Pregnant Women

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical study, to learn more about the safety of COVID-19 vaccines in pregnant women and their babies.

Who can participate?

Pregnant women who are planning to receive the COVID-19 vaccine during their pregnancy may be eligible to participate.

Conditions

  • Pregnancy
  • COVID-19/Coronavirus
  • Adult Studies
  • Healthy Adults
  • Vaccines

What will happen in the study?

The study includes up to 8 study visits, up to 4 of which will be conducted at the Cincinnati Children’s research clinic, and up to 4 visits performed over the phone. You will be in the study for 2 to 7 months depending on how far along you are in your pregnancy when you enroll and when you deliver. Here are some of the things that will happen in this study:

You will:

  • Get your COVID-19 vaccine through a vaccination appointment that you have scheduled (the vaccine is not included in this study).
  • Record your health information for the first 7 days after vaccination(s) with a memory aid form that we will give you.
  • Also be provided with a thermometer and ruler to take your temperature and to measure the spot where you received the vaccine if the area gets red or swollen.
  • Have blood draws.
  • Tell study staff about any changes in your health or the way you feel, especially any colds or respiratory (lung) infections.
  • Sign a medical release to permit us to review medical records for you and your baby, if needed for the hospital where you are planning to deliver.

Also, the study team will collect cord blood from your baby after the umbilical cord is cut, so there is no risk for the baby.

If you are interested in participating in this study, you will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

You or your baby will not have a direct benefit from your taking part in this study. However, the information we learn from this study may help doctors better understand the health effects of COVID-19 vaccine in other pregnant women and their babies.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed prior to the start of the study and include mild discomfort and bruising from the blood draws.

Will you/your child be paid to be in this research study?

Participants will receive up to $300 for time and effort.

Contact

Contact Us.

Study Coordinator
IDStudies@cchmc.org   
513-926-6569

Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.

Elizabeth Schlaudecker, MD, MPH
Infectious Diseases
Cincinnati Children’s Hospital Medical Center