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 :
Recruiting
First Posted : May 20, 2009
Last Update Posted : April 28, 2022
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Condition or disease |
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Inflammatory Bowel Disease |
Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | June 2025 |
Estimated Study Completion Date : | June 2025 |
- 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 ]
- 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 ]
- 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: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904878
Contact: Jessica Lim | 415-885-3734 | jessica.lim@ucsf.edu | |
Contact: Nicole Arima | 415-514-8947 | nicole.arima@ucsf.edu |
United States, California | |
Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations | Recruiting |
San Francisco, California, United States, 94115 | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Jessica Lim 415-885-3734 jessica.lim@ucsf.edu | |
Principal Investigator: Uma Mahadevan, MD |
Principal Investigator: | Uma Mahadevan, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00904878 |
Other Study ID Numbers: |
CCFA Pregnancy Registry CCFA pregnancy Registry ( Other Identifier: Crohn's and Colitis Foundation of America ) |
First Posted: | May 20, 2009 Key Record Dates |
Last Update Posted: | April 28, 2022 |
Last Verified: | April 2022 |
pregnant IBD patients |
Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |