IBD Pregnancy Registry
Observational · No treatment assigned · 1 site · CorEvitas
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (IBD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 50
- Women only
Some of the main requirements, copied from the record:
- Exposed and unexposed cohort:
- A resident of the US or Canada at enrollment
- Currently pregnant
Plus 7 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 832 participants are expected to take part.
- Start date: 2025-04 (planned).
- Main results expected around 2032-09 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Major congenital malformation (Full pregnancy period (~9 months))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (IBD) |
| Lead sponsor | CorEvitas |
| Enrollment | 832 (estimated) |
| Start date | 2025-04 |
| Primary completion (est.) | 2032-09 |
| First posted | 2025-04-04 |
| Last updated | 2025-04-04 |
| Official title | CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR) |
| ClinicalTrials.gov ID | NCT06910553 |
Interventions
- Non-exposed group (Other)
Pregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy - Exposed to IBD pharmacotherapy during pregnancy (Drug)
Pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| PPD | Wilmington, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.