Registry for pregnant individuals with Inflammatory Bowel Disease
CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)
This study is collecting information from pregnant people with Inflammatory Bowel Disease to see how safe their treatments are for them and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 832 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | CorEvitas Research network |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06910553 on ClinicalTrials.gov |
What this trial studies
This registry collects data on pregnant individuals diagnosed with Inflammatory Bowel Disease (IBD) to assess the safety of IBD pharmacotherapies during pregnancy. It aims to estimate the prevalence of major congenital malformations and other maternal, fetal, and infant outcomes among those exposed to IBD treatments compared to those who are not. The registry will provide real-world evidence to help healthcare professionals make informed decisions regarding the management of IBD in pregnant patients.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 18 to 50 with a physician-confirmed diagnosis of IBD residing in the US or Canada.
Not a fit: Patients who are exposed to methotrexate during pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve understanding of the safety of IBD medications during pregnancy, leading to better health outcomes for mothers and infants.
How similar studies have performed: Other studies have shown success in assessing the safety of medications during pregnancy, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wilmington, North Carolina
- Ppd — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Ronna L Chan, PhD, MPH — PPD, Part of Thermo Fisher Scientific
- Study coordinator: Ronna L Chan, PhD, MPH
- Email: ibd-pr@corevitas.com
- Phone: 800-616-3791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.