Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337565
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Brief Title:
Safety of IBD Drugs During Pregnancy and Breasfeeding Mothers and Babies Outcomes
Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Organization:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Overview
Official Title:
Safety of IBD Drugs During Pregnancy and Breasfeeding Mothers and Babies Outcomes DUMBO 2 Registry
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None