IBD Pregnancy Registry

NCT06910553 | Recruiting

• 1 other identifier: IBDPR-310
• Study Type: observational
• Target: 832
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Pregnant; IBD; Registry; UC; Inflammatory Bowel Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Major congenital malformation

  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.

  Full pregnancy period (~9 months)

Secondary Outcomes (16)

• Minor congenital malformation

  Full pregnancy period (~9 months)

• Spontaneous abortion

  <20 gestational weeks

• Pregnancy termination

  Full pregnancy period (~9 months)

• Preeclampsia

  Full pregnancy period (~9 months)

• Eclampsia

  Full pregnancy period (~9 months)

Study Arms (2)

IBD pharmacotherapy exposed

Individuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy

Drug: Exposed to IBD pharmacotherapy during pregnancy

IBD pharmacotherapy unexposed

Individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy

Other: Non-exposed group

Interventions

Non-exposed group OTHER

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

IBD pharmacotherapy unexposed

Exposed to IBD pharmacotherapy during pregnancy DRUG

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

IBD pharmacotherapy exposed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant individuals across the US \& Canada who learn of the study via nationwide advertising campaigns or via their healthcare providers

You may qualify if:

• Exposed and unexposed cohort:
• A resident of the US or Canada at enrollment
• Currently pregnant
• 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

You may not qualify if:

• Exposed and unexposed cohort:
• Exposure to methotrexate during pregnancy

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

PPD

Wilmington, North Carolina, 28401, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Ronna L Chan, PhD, MPH

  PPD, Part of Thermo Fisher Scientific

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronna L Chan, PhD, MPH

CONTACT

800-616-3791; ibd-pr@corevitas.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)