RECRUITING

IBD Pregnancy Registry

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR)

Quick Facts

Study Start:2025-04
Study Completion:2032-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06910553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * A resident of the US or Canada at enrollment
  2. * Currently pregnant
  3. * 18 to 50 years of age at enrollment
  4. * Physician-confirmed diagnosis of IBD (UC, CD, other and unspecified noninfective gastroenteritis and colitis \[ICD-10 K52\] and indeterminate colitis \[ICD-10 K52.3\])
  5. * 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
  6. * Authorize their HCP to provide data to the registry
  7. * Provide contact information (for participant and HCPs)
  1. * Exposure to methotrexate during pregnancy

Contacts and Locations

Study Contact

Ronna L Chan, PhD, MPH
CONTACT
800-616-3791
ibd-pr@corevitas.com

Principal Investigator

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

Study Locations (Sites)

PPD
Wilmington, North Carolina, 28401
United States

Collaborators and Investigators

Sponsor: CorEvitas

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2032-09

Study Record Updates

Study Start Date2025-04
Study Completion Date2032-09

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Inflammatory Bowel Disease (IBD)