Inflammatory Bowel Disease
Conditions
Keywords
pregnant IBD patients
Brief summary
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease study is being conducted at the University of California San Francisco and 30 other sites around the United States who are part of the CCFA Clinical Alliance. The aim of this study is to determine the effect of medication use and disease activity on the outcome of pregnancy among women with IBD up to 18 years from birth.
Detailed description
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
Interventions
None listed
Sponsors
University of California, San Francisco
Crohn's and Colitis Foundation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
Exclusion criteria
* Pregnant female patients younger than 18 years of age * Confirmed multiple gestation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether children born to women with IBD have higher rates of developmental delay compared to their age matched non-IBD peers, as measured by the Ages and Stages Questionnaire (ASQ-3) at ages 12, 24, 36, and 48 months | December 2014 |
Secondary
| Measure | Time frame |
|---|---|
| Determine whether the rate of any adverse pregnancy outcomes in a prospective national sample of women from the United States with IBD differ with respect to exposure to azathioprine/6MP or anti-TNF therapy | December 2014 |
Countries
United States
Contacts
CONTACTJessica Lim
CONTACTNicole Arima
PRINCIPAL_INVESTIGATORUma Mahadevan, MD
University of California, San Francisco
Outcome results
None listed