Safety of IBD Drugs During Pregnancy and Breastfeeding: Mothers and Babies' Outcomes (DUMBO Registry)

In plain English

What this trial is testing

Condition(s) listed: Inflammatory Bowel Diseases and Pregnancy. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

• Ages 18 and older
• Women only

Some of the main requirements, copied from the record:

• Patients over 18 years of age diagnosed with IBD.
• Confirmed pregnancy.
• Awareness of the pregnancy (by the researcher) before week 28th of gestation (the end of the second trimester).

There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 1750 participants are expected to take part.
• Start date: 2019-05-21.
• Main results expected around 2024-03-01 (estimate from the record).
• 73 study sites listed (31 marked recruiting) in Spain.

Main thing being measured

• To calculate the incide rate of serious infections during pregnancy (evaluated and the end of pregnancy) based on the medications used to treat IBD. (9 months)

In the researchers’ words

This is a prospective, observational, multicenter registry, which will enrol pregnant women with IBD (CD, UC, or unclassified IBD) over 5 years in Spain. In addition, each incident gestation will be followed-up during pregnancy, and children born to those mothers will be followed-up over 4 years to determine the incidence of serious adverse events (such as alteration of developmental status, infections, neoplasia or…

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.