The purpose of this research is to learn more about the health of pregnant individuals and infants born to these individuals who receive treatment for inflammatory bowel disease (IBD) during pregnancy. Inflammatory bowel disease is a group of disorders of the intestine that cause redness and swelling (together called inflammation) of the digestive tract. This causes abdominal pain, cramping, and unexplained weight loss. This research study will involve subjects with an IBD diagnosis, specifically of:

Ulcerative colitis: a condition in which ulcers are formed in the intestine,

Crohn’s disease: a condition in which inflammation and irritation in digestive tract occurs

Unspecified non infective gastroenteritis: (a condition characterized by inflammation and irritation of the stomach and intestines)

Indeterminate colitis: a temporary diagnosis used when a patient has inflammatory bowel disease but can’t be definitively diagnosed with ulcerative colitis or Crohn’s disease

We expect that your taking part in this research will last from the time you enroll until your infant is 12 months of age.

IBD-PR is an observational research study for pregnant adults with IBD including Ulcerative Colitis, indeterminate colitis, other and unspecified noninfective gastroenteritis, or Crohn’s Disease.

It is designed to help us learn more about the ongoing health of pregnant individuals, as well as their infant after they’re born. An observational study means researchers are only observing and won’t ask you to do anything except provide information about your health. Researchers won’t interfere with any decisions you make with your usual healthcare team regarding your routine care, treatments or tests.

Data collection will span the entire pregnancy, with data collected at enrollment, at the end of the second trimester, at pregnancy outcome, and after giving birth when infants are 4 and 12 months of age.

Inflammatory bowel disease (IBD) is a group of chronic inflammatory conditions that affect the digestive tract and can be divided into two main types: Crohn’s disease (CD) and ulcerative colitis (UC). Of note is that half of those diagnosed with IBD received their diagnosis before age 35—during their peak reproductive years.

• Ulcerative colitis involves inflammation (swelling) and ulcers (sores) along the lining of the large intestine (colon) and rectum.
• Crohn’s disease involves inflammation (swelling) of the lining of the digestive tract. It usually affects the small intestine but can also affect the large intestine and even the upper GI tract, though rarely.
• Unspecified non infective Gastroenteritis involves inflammation and irritation of the stomach and intestines.
• Indeterminate colitis: a temporary diagnosis used when a patient has inflammatory bowel disease but can’t be definitively diagnosed with ulcerative colitis or Crohn’s disease.

Symptoms can be similar for both conditions and typically include diarrhea, rectal bleeding, belly pain, nausea, fatigue and weight loss. Disease severity, however, can vary widely among individuals.

If you are pregnant and have IBD, we need you to answer some questions about your pregnancy and your health. You will share your information by filling out online forms. We will also follow-up with your and your infant’s healthcare providers to gather additional information, as needed. You do not “have” to do anything and may stop participating at any time.

Also, even if you do not actually give birth due elective termination or miscarriage, for example, we still want to collect your data. In other words, ALL pregnant individuals with IBD are eligible to enroll regardless of the outcome their pregnancy.

IBD-PR will ask questions of you and/or your healthcare providers about the following, among other things:

• Your background (such as your age and education level)
• Your height and weight
• Your overall health/your IBD
• Your current pregnancy and pregnancy/medical history
• Any medicines and vitamins you are taking
• Your baby’s health (such as their growth and weight gain)

Researchers will analyze the information from IBD-PR participants and healthcare providers to identify trends, similarities, and differences to answer research questions regarding the treatment of IBD during pregnancy.

Your participation in IBD-PR will contribute to establishing a body of knowledge that could help medical researchers advance medical science, particularly with respect to the treatment of pregnant people with IBD (and their infants) in the future.

Also, in exchange for your time, you may be compensated up to $50 for completing the study-related tasks, which are to fill out a form related to you, your IBD and your pregnancy and to complete medical release forms so your and your infant’s health care providers can provide healthcare information (as noted above).

This research involves no more than minimal risk to participants as, again, this is an observational ONLY study and poses no possibility of physical harm.

Like any online activity, however, there is a risk of loss of privacy, but the registry has well-established procedures in place to prevent any such breach with extensive safeguards in place to ensure that your privacy is protected. (For more details on privacy risks, please see the Consent Form or the Privacy Policy.)

You may qualify if:

• You are currently pregnant
• You are 15 to 50 years of age
• You have been diagnosed with IBD (Ulcerative Colitis, indeterminate colitis, other and unspecified noninfective gastroenteritis, or Crohn’s Disease) by a physician
• You are a resident of the United States or Canada

Ideally, we need people of all backgrounds to join our study in order to ensure our future treatment recommendations will work for a wide range of pregnant adults with IBD.

IBD-PR is being conducted by CorEvitas with financial support from Pfizer. The IBD-PR will provide secondary data for the Etrasimod Post Approval Safety Study (PASS).

In general, only a few people from the IBD-PR Study Team and the website developers will see your personal information. These individuals are trained to protect patient privacy and keep data secure. IBD-PR will not share your name or other personal information with anyone else, except in specific situations noted in the Informed Consent Form.

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 or other personal information that could reveal your identity. They will study the de-identified information from IBD-PR to look for trends or common issues that many individuals, or certain groups of individuals, may experience.

IBD-PR may also share de-identified information with other databases, registries, and data repositories. Combining IBD-PR data with other sources may help us expand our knowledge about pregnancy and could lead to new study ideas and future treatments.

IBD-PR follows strict rules to protect your privacy, including relevant federal laws and regulations. Again, only a few chosen people on the IBD-PR Study Team will know that you are part of IBD-PR and will have access to your information. However, there are exceptions to this situation listed in the Consent form. For additional information, please see the Privacy Policy and Disclaimers and Policies documents available through IBD-PR.

No. IBD-PR will not tell anyone that you, specifically, are part of the study.

If you decide to take part in this research study, the general procedures will include providing information about yourself and your health through the completion of study form(s) and providing permission for your and your infant’s healthcare provider(s) to provide information about the pregnancy and your baby.

IBD-PR will maintain all 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 IBD-PR 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 IBD-PR, 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 IBD-PR database from your computer or mobile device.

After IBD-PR 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 IBD-PR will continue to be available for researchers to study for many years after the project ends.

Any adult who is pregnant, has received a diagnosis of IBD, and who is between 18 and 50 years of age may be 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 IBD-PR.

If you have already joined IBD-PR, a copy of your signed Consent form is available on the Dashboard.

It is your decision to take part in IBD-PR. You can decide to stop participating at any time. You do not need to provide a reason for stopping your participation.

To withdraw from IBD-PR, you can send an email to the IBD-PR Study Team at IBD-PR@COREVITAS.COM. Please specify in your email whether you want to:

Stop answering IBD-PR questionnaires and stop receiving IBD-PR email reminders and other messages,

OR

Remove all of your information from the active database.

Yes, you can! Simply click the button below.