IBD Pregnancy Registry

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
CorEvitas
Study ID
NCT06910553
Status
Recruiting
Apply to this trial

Conditions

  • Inflammatory Bowel Disease (IBD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-exposed group — OTHER
    Pregnant individuals with IBD who are not exposed to an IBD pharmacotherapy during pregnancy
  • Exposed to IBD pharmacotherapy during pregnancy — DRUG
    Pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Apr 2025
Primary completion
Sep 30, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
832 participants (estimated)

Arms

  • Arm: IBD pharmacotherapy exposed
    Individuals with a diagnosis of IBD who are exposed to an approved IBD pharmacotherapy at any time during pregnancy
  • Arm: IBD pharmacotherapy unexposed
    Individuals with a diagnosis of IBD who are not exposed to IBD pharmacotherapy during pregnancy

Primary Outcome Measure

Major congenital malformation [ Time Frame: Full pregnancy period (~9 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PPDWilmingtonNorth Carolina28401
CorEvitas Clinical Research Associate
[email protected]
1-800-616-3791

Find similar trials in Wilmington, NC

By research site
PPD· Wilmington, NC

Related Studies