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IBD Pregnancy Registry

NCT06910553 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 832

Last updated 2025-04-04

No results posted yet for this study

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)

Interventions

OTHER

Non-exposed group

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

DRUG

Exposed to IBD pharmacotherapy during pregnancy

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

Sponsors & Collaborators

  • CorEvitas

    lead NETWORK

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2032-09-30
Completion
2032-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06910553 on ClinicalTrials.gov