RecruitingNCT06910553

IBD Pregnancy Registry

CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)


Sponsor

CorEvitas

Enrollment

832 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is building a pregnancy registry to track health outcomes in pregnant women with inflammatory bowel disease (IBD — such as Crohn's disease or ulcerative colitis), including both those who are taking IBD medications and those who are not, to better understand the safety of these treatments during pregnancy. **You may be eligible if...** - You are currently pregnant - You are between 18 and 50 years old - You live in the US or Canada - You have a physician-confirmed diagnosis of IBD (Crohn's disease, ulcerative colitis, or related bowel condition) - You are willing to share your health information and provide contact details for yourself and your healthcare provider **You may NOT be eligible if...** - You are not currently pregnant - You do not have a confirmed IBD diagnosis - You are outside the US or Canada Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-exposed group

Pregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy

DRUGExposed to IBD pharmacotherapy during pregnancy

Pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy


Locations(1)

PPD

Wilmington, North Carolina, United States

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NCT06910553


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