Status:
RECRUITING
IBD Pregnancy Registry
Lead Sponsor:
CorEvitas
Conditions:
Inflammatory Bowel Disease (IBD)
Eligibility:
FEMALE
18-50 years
Brief Summary
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 a...
Detailed Description
Rationale and Background: Inflammatory bowel disease (IBD) is a group of chronic inflammatory conditions that affect the gastrointestinal tract and can be divided into two main types: Crohn's disease...
Eligibility Criteria
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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
832 Patients enrolled
Trial Details
Trial ID
NCT06910553
Start Date
April 1 2025
End Date
September 1 2032
Last Update
April 4 2025
Active Locations (1)
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1
PPD
Wilmington, North Carolina, United States, 28401