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IBD Pregnancy Registry

This study is a registry for pregnant individuals with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. It aims to understand the safety of IBD medications during pregnancy. You can join if you are pregnant, between 18 and 50 years old, live in the US or Canada, and have a doctor-confirmed IBD diagnosis. The study will compare two groups: those who take IBD medications during pregnancy and those who don't. The main goal is to see if there's a higher chance of major birth defects in babies whose mothers took IBD medications. Researchers also want to learn about other health outcomes for mothers, babies, and infants up to one year after birth. The study plans to enroll 832 participants.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It plans to enroll 832 pregnant individuals with IBD.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, major congenital malformation, is measured over the full pregnancy period (about 9 months). The study also aims to collect data on infant outcomes during the first year of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06910553

IBD Pregnancy Registry

Recruiting
Not specifiedAges 18–50Observational
CorEvitas
~832 participants
Updated 2025-04-04 on ClinicalTrials.gov
What's tested:Non-exposed groupExposed to IBD pharmacotherapy during pregnancy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major congenital malformation
Measured over Full pregnancy period (~9 months)

Conditions

Inflammatory Bowel Disease (IBD)

Explore related trials

Colitis of Indeterminate TypeCrohn DiseaseInflammatory Bowel DiseaseUlcerative Colitis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Ronna L Chan, PhD, MPH · PRINCIPAL_INVESTIGATOR · PPD, Part of Thermo Fisher Scientific

Who to contact

Ronna L Chan, PhD, MPH
[email protected]
800-616-3791
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

Exposure to methotrexate during pregnancy

What this trial measures

  • Major congenital malformationFull pregnancy period (~9 months)

    An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.