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NCT06910553 · ClinicalTrials.gov registry record

IBD Pregnancy Registry

A clinical trial of Inflammatory Bowel Disease (IBD), sponsored by CorEvitas.

Recruiting
Registry status
832
Enrollment target
1
Study location

NCT06910553 is a study of Inflammatory Bowel Disease (IBD) that is actively recruiting participants, run by CorEvitas. The registered enrollment target is 832 participants, above the 205-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (306% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06910553, a study of Inflammatory Bowel Disease (IBD), is actively recruiting participants, sponsored by CorEvitas.

RECRUITING
Registry status
832 participants
Enrollment target
1
Study location

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.

Interventions

  • OTHER Non-exposed group
  • DRUG Exposed to IBD pharmacotherapy during pregnancy

Study Locations (1)

North Carolina

  • PPD - Wilmington

Trial Details

FieldValue
Enrollment Target 832 participants
Start Date 2025-04
Est. Completion 2032-09

Sponsor

CorEvitas

13 total trials

What the Registry Record Tells You About NCT06910553

The ClinicalTrials.gov registry entry for NCT06910553 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 832 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 205-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (306% higher). The listed sponsor is CorEvitas, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Inflammatory Bowel Disease (IBD) appearing as the primary indexed condition, and to 2 interventions - of which Non-exposed group is the first listed.

NCT06910553 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT06910553 about?

NCT06910553 is a clinical study titled "IBD Pregnancy Registry". 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 D...

What is the current status of trial NCT06910553?

This trial is currently recruiting. The enrollment target is 832 participants. The study started on 2025-04. Estimated completion is 2032-09.

What conditions does trial NCT06910553 study?

This clinical trial studies the following conditions: Inflammatory Bowel Disease (IBD).

What interventions are being tested in trial NCT06910553?

The interventions under investigation include: Non-exposed group (OTHER), Exposed to IBD pharmacotherapy during pregnancy (DRUG).

Who is sponsoring clinical trial NCT06910553?

This trial is sponsored by CorEvitas, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06910553 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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