Registry following pregnancies in people with inflammatory bowel disease
Records outcomes of pregnancies in people with inflammatory bowel disease who take IBD medicines.
Plain-language title generated from the registry record
Registry title: IBD Pregnancy Registry
Key facts
- Where
- Wilmington, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT06910553, who can take part
Where in United States
- PPDWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CorEvitas
- Trial code
- NCT06910553
- Record updated
- 4 April 2025
- Original description
Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following:Read full original descriptionShow less
CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
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.
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 [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: Exposed and unexposed cohort:; Exposure to methotrexate during pregnancy.