| NCT ID | NCT06910553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CorEvitas |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 832 participants |
| Start Date | 2025-04 |
| Primary Completion | 2032-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 832 participants in total. It began in 2025-04 with a primary completion date of 2032-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Ronna L Chan, PhD, MPH
PRINCIPAL INVESTIGATOR
PPD, Part of Thermo Fisher Scientific
Frequently Asked Questions
Who can join the NCT06910553 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06910553 currently recruiting?
Yes, NCT06910553 is actively recruiting participants. Contact the research team at ibd-pr@corevitas.com for enrollment information.
Where is the NCT06910553 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT06910553 clinical trial?
NCT06910553 is sponsored by CorEvitas. The principal investigator is Ronna L Chan, PhD, MPH at PPD, Part of Thermo Fisher Scientific. The trial plans to enroll 832 participants.