Ustekinumab and Risk of Small for Gestational Age in Inflammatory Bowel Disease Pregnancies: Data from the DUMBO Registry

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001012
• Study ID:
  1000001012
• Official title and acronym:
  Ustekinumab and Risk of Small for Gestational Age in Inflammatory Bowel Disease Pregnancies: Data from the DUMBO Registry
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This study is a retrospective observational cohort analysis based on data extracted from the DUMBO registry (Safety Of IB(D) Dr(U)gs During Pregnancy And Breastfeeding: (M)others and (B)abies’ (O)utcomes), a prospective Spanish multicenter registry designed to evaluate maternal and neonatal outcomes in women with inflammatory bowel disease (IBD) exposed to IBD therapies during pregnancy. The objective of the study is to compare the incidence rates of small for gestational age (SGA) infants born to women with IBD exposed to ustekinumab (including biosimilars) during pregnancy to those exposed to anti-tumor necrosis factor alpha (TNFɑ) agents (infliximab, adalimumab, golimumab, including biosimilars) or to immunomodulators (including corticosteroids) or to either biologics or immunomodulators.
• Study status:
  Finalised

Research institutions and networks

Institutions

GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)

Study timelines

Date when funding contract was signed

Actual:03/03/2026

Study start date

Actual:01/05/2019

Data analysis start date

Actual:03/03/2026

Date of final study report

Planned:15/05/2026

Actual:19/05/2026

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable