COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)
What is the C-VIPER?
The C-VIPER is a research study that focuses on gathering information. We are asking women who were vaccinated against COVID-19 during pregnancy to answer questions about their pregnancies, their health, and their babies’ health. Asking questions and collecting information from pregnant women themselves provides a unique perspective from other studies that rely on doctors or nurses to provide information about their pregnant patients.
The C-VIPER will ask questions about:
- Your background (such as your age and education level)
- Your pregnancy (such as your expected date of delivery, your weight at various time points and medications you are using)
- Your overall health (such as any pre-pregnancy medical conditions or pregnancy-related problems)
- Your COVID-19 vaccination
- Your current health status
- Your labor and delivery (such as C-section or vaginal birth and length of labor)
- Your baby’s health (such as his or her growth and weight gain)
Researchers will examine the information from C-VIPER participants to identify trends, similarities, and differences and to answer research questions regarding vaccination against COVID-19 and pregnancy.
What is a research study?
A research study is a project that aims to learn more about a specific topic, in this case, COVID-19 vaccines and pregnancy.
Many research studies collect information about health, medical care, or medical treatments. There are different types of research studies. C-VIPER is an observational study, meaning that it is only collecting information (observing the participants). Another type of research study — called a clinical trial — tests whether a new drug or other medical treatment safely and effectively improves patient health. C-VIPER is not testing any medical treatments.
What is the C-VIPER trying to learn?
Using data collected directly from pregnant women, the C-VIPER is trying to answer questions about the COVID-19 vaccines during pregnancy. There is not much information available about whether the COVID-19 vaccines are safe to the mother when used in pregnancy, on the developing fetus, and on the newborn.
We hope the C-VIPER will provide women and health care providers with the information they need to make informed decisions about COVID-19 vaccines.
What are the benefits of joining the C-VIPER?
By joining C-VIPER and answering questions like those listed earlier, you can help improve care for other pregnant women with COVID-19 in the future.
By taking part in the C-VIPER, you will be able to see how your pregnancy experiences compare to those of other women in the study, since aggregate results of the Registry will be reported to participants.
You and your baby may not benefit directly from joining the C-VIPER. But giving your health information might help us learn whether COVID-19 vaccines are safe when used during pregnancy to mothers and their babies.
What are the risks of joining the C-VIPER?
Who is eligible for the C-VIPER?
The C-VIPER is open to any woman who is 18 years of age or older, pregnant, and vaccinated against COVID-19 during pregnancy.
Who is sponsoring the C-VIPER?
The C-VIPER is funded by Pregistry, LLC.
Whom should I contact if I have any questions?
If you have any problems or questions about this study, or about your rights as a research participant, or about any research-related issue, contact the Principal Investigator, Dr. Diego Wyszynski, at CVIPER@pregistry.com.
To be eligible to register in the C-VIPER, you must be:
- 18 years of age or older
- Currently pregnant
- Received at least one dose of a COVID-19 vaccine during pregnancy
- Read and understand the online modules, be willing to sign the inform consent and to enter the answers to some basic questions
If you have not been vaccinated against COVID-19 during pregnancy, please do not register.
The C-VIPER will be available in other languages in the near future.
Who will see my information?
Only the Principal Investigator, Clinical Quality Associates, Clinical Research Associates, and the Study Administrator will see your personal information. These individuals are trained to protect patient privacy and keep data secure. C-VIPER will not share your name, address, and other personal information with anyone else.
In the database, we will replace your name with a code number to hide your identity in the data. Only qualified and approved scientists and researchers will have access to this "de-identified" or "coded" data, meaning they will not have access to your name, address, or other personal information that could reveal your identity. They will study the de-identified information from the C-VIPER to look for trends or common issues that many women, or certain groups of women, may experience. For instance, they might discover that 4,000 out of 10,000 C-VIPER participants reported having severe muscle pain shortly after the vaccination. But they won’t know who any of those women are. The C-VIPER may also share de-identified information with other databases, registries, and data repositories. Combining C-VIPER’s data with other sources may help us expand our knowledge about pregnancy and could lead to new study ideas and future treatments.
Will you tell anyone that I am taking part in the C-VIPER?
No. The C-VIPER will not reveal to anyone that you, specifically, are part of the project.
How secure is my information?
The C-VIPER will maintain all of the information you provide in a safe, secure computer database that conforms with government security requirements, including the Federal Information Security Management Act of 2002 (FISMA, 44 U.S.C. § 3541).
The first step in securing your information is for you to use a password that is difficult for someone to guess and that you do not share with anyone. In addition, if you are accessing C-VIPER using a cell phone or other mobile device, having a passcode on your device will improve security of your data. Although we are using many tools and practices to ensure the security of information saved in the C-VIPER, we cannot guarantee the security of data on your computer or mobile device. We also cannot guarantee the security of data while it is being sent to the C-VIPER database from your computer or mobile device.
What happens to my information when the C-VIPER ends?
After the C-VIPER ends, we will continue to keep the information you provided in a secure database, and your identity will remain protected. De-identified data—data without participants’ identities or any information that could reveal their identities—from the C-VIPER will continue to be available for researchers to study for many years after the project ends. The C-VIPER de-identified data may be requested by doctors, scientists, and other interested parties who want to do their own research on pregnancy and/or who want figure out how many the C-VIPER participants may be eligible for other research studies.
Who can "sign" the consent form?
Any woman who is pregnant and older than 18 years of age and who can complete the consent form for herself is eligible. Selecting the appropriate prompts in the consent form constitutes an electronic signature of the form and signifies acceptance of the risks and benefits involved in the C-VIPER.
If you have already joined C-VIPER, a copy of your signed Consent form is available in Edit Profile.
What if I change my mind about being in the C-VIPER?
It is your decision to take part in C-VIPER. You can decide to stop participating at any time: just stop entering information. You do not need to provide a reason for stopping your participation.
To withdraw from the C-VIPER, you can send an email to the C-VIPER Coordinators at email@example.com. Please specify in your email whether you want to:
Stop answering C-VIPER questionnaires and stop receiving the C-VIPER email reminders and other messages, or
Remove all of your information from the active database. Please keep in mind that we cannot get back any of your data included in de-identified data that was shared before the C-VIPER received and processed your request for removal.
Can I Register Now?
Yes, you can! Please, click the green button below.