Home › Inflammatory Bowel Disease › NCT06910553
IBD Pregnancy Registry
CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
Who can join
Ages 18 to 50 · Women
Full 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
About the study
Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:
Research question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy?
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.
The secondary objectives of the registry are:
To estimate the prevalence of other maternal, fetal, and infant outcomes among pregnant individuals with IBD who are exposed to IBD pharmacotherapies during pregnancy.
To contextualize the prevalence of outcomes among pregnant individuals who are exposed to IBD pharmacotherapies during pregnancy and estimate the prevalence of all outcomes of interest among pregnant individuals with IBD who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.
If sample size permits, to estimate the risk ratio for each outcome, comparing the outcomes of pregnant individuals with IBD who are exposed to IBD pharmacotherapy with those who are not exposed to any IBD pharmacotherapies or an IBD pharmacotherapy of interest during pregnancy.
Data collection may be used to determine pharmacotherapy-specific use with or without unexposed cohorts on an as-needed basis, as sample size allows.
What is being tested
- Non-exposed group (other)
- Exposed to IBD pharmacotherapy during pregnancy (drug)
Sponsor: CorEvitas · Participants: 832 · Started: 2025-04
Contact the study team
- Ronna L Chan, PhD, MPH · Phone: 800-616-3791
Official record on ClinicalTrials.gov — NCT06910553
Locations in the U.S.
| North Carolina | PPD, Wilmington |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.