About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
Disqualifiers
Pregnant female patients younger than 18 years of age
Confirmed multiple gestation
Trial population
Female patients with confirmed IBD diagnoses who are pregnant
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
Other outcomes
Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD
Sponsors and contacts
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University of California, San Francisco
Lead sponsor
Crohn's and Colitis Foundation
Collaborator