CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
Published: 07/02/2025
General Information:
The primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy.
Eligibility:
Inclusion (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, and indeterminate colitis)
Inclusion (exposed cohort only):
Exposed to an IBD pharmacotherapy during pregnancy
Exclusion (exposed and unexposed cohort):
Exposure to methotrexate during pregnancy
Study Details:
Study description/explanation of participation:
This prospective, observational cohort study is designed to estimate the
prevalence of maternal, fetal, and infant outcomes among individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy. This registry will collect data from participants and healthcare providers involved in their care or the care of their infants via concise data collection forms at predefined timepoints during pregnancy, at pregnancy outcome, and up to 1 year of infant age.
Description of treatment or intervention (mechanism of action):
No intervention on this observational study.
Patient Participation Requirements:
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, and indeterminate colitis)
Possible risks and side effects:
No possibility of physical harm. Only risk is breach of confidentiality