A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
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ClinicalTrials.gov Identifier: NCT00904878
Recruitment Status : Unknown
Verified January 2016 by University of California, San Francisco. Recruitment status was: Recruiting
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 4 years from birth.
Condition or disease
Inflammatory Bowel Disease
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
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 [ Time Frame: December 2014 ]
Secondary Outcome Measures :
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 [ Time Frame: December 2014 ]
Other Outcome Measures:
Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD [ Time Frame: December 2014 ]
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Female patients with confirmed IBD diagnoses who are pregnant
Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
Pregnant female patients younger than 18 years of age