Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status: Enrolling

Conditions: Drusgs for IBD

Study type: Observational

Funder types: Other

Identifiers

NCT06337565

GIS-DUMBO 2-2024

Details and patient eligibility

About

This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age diagnosed with IBD.
• Confirmed pregnancy.
• - Treatment with non-anti-TNF biologics or other advanced therapies (i.e JAK inhibitors, S1P receptor modulators and molecules approved in the forthcoming years).

Exclusion criteria

• Patients who do not accept to participate in the study