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:
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.
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:
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.
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 firstname.lastname@example.org. Please specify in your email whether you want to: