New registry tracks IBD drug risks for moms and babies

NCT ID NCT06337565

Recruiting now Knowledge-focused Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study will follow 1,000 pregnant women with inflammatory bowel disease (IBD) who are taking newer medications (non-anti-TNF biologics or targeted small molecules). Researchers will track serious infections and other adverse events in mothers and their children up to 4 years old. The goal is to fill a critical gap in safety data, since pregnant women are typically excluded from drug trials.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

What this could lead to: If successful, this study could provide much-needed safety data on newer IBD drugs during pregnancy, helping doctors and patients make informed treatment decisions.
What could go wrong: This is an observational registry, not a controlled trial, so it can show associations but not prove cause and effect. The number of participants may be small, limiting the strength of conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DRUSGS FOR IBD

Contacts and locations

Locations

Hospital Universitario de La Princesa
RECRUITING

Madrid, Madrid, 28006, Spain

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