IBD Pregnancy Registry

Launched by COREVITAS · Apr 2, 2025

Keywords

ClinConnect Summary

The IBD Pregnancy Registry is a research study designed to learn more about the effects of Inflammatory Bowel Disease (IBD) treatments on pregnant individuals and their babies. The main goal of this trial is to find out if there is a higher risk of serious health issues for mothers, unborn babies, or newborns when mothers use IBD medications during pregnancy. Researchers will collect information to see how common major birth defects and other health outcomes are in pregnant individuals with IBD who take these medications compared to those who do not.

To participate in this study, you need to be a woman aged 18 to 50 years, currently pregnant, and living in the U.S. or Canada. You must have a doctor-confirmed diagnosis of IBD and agree to let your healthcare provider share your information with the registry. The study is open to both those who are taking IBD medications during their pregnancy and those who are not. If you join, you'll be asked to provide some personal information and consent to participate, but you will not be able to join if you have been treated with methotrexate during your pregnancy. This trial is actively recruiting participants, so if you meet the criteria and are interested, you could help advance our understanding of IBD and pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Exposed and unexposed cohort:
• • A resident of the US or Canada at enrollment
• • Currently pregnant
• • 18 to 50 years of age at enrollment
• • Physician-confirmed diagnosis of IBD (UC, CD, other and unspecified noninfective gastroenteritis and colitis \[ICD-10 K52\] and indeterminate colitis \[ICD-10 K52.3\])
• • Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant institutional review board (IRB)/independent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• • Authorize their HCP to provide data to the registry
• • Provide contact information (for participant and HCPs)
• Exposed cohort only:
• • - Exposed to an IBD pharmacotherapy during pregnancy
• Exclusion Criteria:
• Exposed and unexposed cohort:
• • Exposure to methotrexate during pregnancy