What is the IRCEP?

The IRCEP is a research study that focuses on gathering information. We are asking pregnant women infected or potentially infected with SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), 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 IRCEP 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 status with respect to COVID-19
  • 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 IRCEP participants to identify trends, similarities, and differences and to answer research questions regarding 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 in pregnancy.

Many research studies collect information about health, medical care, or medical treatments. There are different types of research studies. IRCEP 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. IRCEP is not testing any medical treatments.

What is the IRCEP trying to learn?

Using data collected directly from pregnant women, the IRCEP is trying to answer questions about COVID-19 in pregnancy. There is not much information available about COVID-19 and its potential effect on pregnancy, on the developing fetus, and on the newborn.

We hope the IRCEP will provide women and health care providers with the information they need to make informed decisions. This will then mean better management and treatment of pregnant women with COVID-19.

What are the benefits of joining the IRCEP?

By joining IRCEP 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 IRCEP, 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 IRCEP. But giving your health information might help us find better ways to care for pregnant women with COVID-19 and their babies in the future.

What are the risks of joining the IRCEP?

There are no known physical risks of taking part in the IRCEP. But, like any online activity, there is always a risk of loss of privacy. For more details on privacy risks, please see the Consent form (if you have already joined IRCEP, a copy is saved in the My Profile section) or the Privacy Policy.

Who is eligible for the IRCEP?

The IRCEP is open to any woman who is 18 years of age or older, pregnant or recently pregnant, diagnosed with COVID-19 or tested for COVID-19 (regardless of the result) during pregnancy. If a health care professional (such as doctor, nurse, midwife) told you that you have (or had) COVID-19 at anytime during your pregnancy, you can participate in the Registry even if you have not been tested for COVID-19.

Who is sponsoring the IRCEP?

The IRCEP 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 IRCEP@pregistry.com.

To be eligible to register in the IRCEP, you must be:

  • 18 years of age or older
  • Currently pregnant or pregnant in the last 6 months
  • Have a clinical diagnosis (based on signs and symptoms) of COVID-19 by a health care professional (e.g., doctor, nurse, midwife) at anytime during pregnancy OR have been tested (regardless of the result) at anytime during pregnancy
  • Read and understand English, be willing to sign the inform consent and to enter the answers to some basic questions

If you have never been diagnosed with COVID-19 during pregnancy or have never had a test for COVID-19, please do not register.

The IRCEP will be available in other languages in the near future.

Who will see my information?

In general, only the IRCEP Coordinators and the website developers will see your personal information. These individuals are trained to protect patient privacy and keep data secure. IRCEP 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 IRCEP 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 IRCEP participants reported having severe morning sickness in the first 3 months of pregnancy. But they won’t know who any of those women are. The IRCEP may also share de-identified information with other databases, registries, and data repositories. Combining IRCEP’s data with other sources may help us expand our knowledge about pregnancy and could lead to new study ideas and future treatments.

The IRCEP follows strict rules to protect your privacy, including relevant federal laws and regulations. Generally, only the IRCEP Coordinators will know that you are part of the IRCEP and will have access to your information. However, there are a few exceptions to this situation that are listed in the Consent form (if you have already joined IRCEP, a copy is saved in the My Profile section). For additional information, please see the Privacy Policy and Disclaimers and Policies documents available through the IRCEP.

Will you tell anyone that I am taking part in the IRCEP?

No. The IRCEP will not reveal to anyone that you, specifically, are part of the project.

How secure is my information?

The IRCEP 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 create a username and password that is difficult for someone to guess and that you do not share with anyone. In addition, if you are accessing IRCEP 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 IRCEP, 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 IRCEP database from your computer or mobile device.

What happens to my information when the IRCEP ends?

After the IRCEP 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 IRCEP will continue to be available for researchers to study for many years after the project ends. The IRCEP 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 IRCEP 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 IRCEP.

If you have already joined IRCEP, a copy of your signed Consent form is available in My Profile.

What if I change my mind about being in the IRCEP?

It is your decision to take part in IRCEP. 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 IRCEP, you can send an email to the IRCEP Coordinators at ircep@pregistry.com. Please specify in your email whether you want to:
  • Stop answering IRCEP questionnaires and stop receiving the IRCEP 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 IRCEP received and processed your request for removal.

Yes, you can! Please, click the green button below.