A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
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| ClinicalTrials.gov Identifier: NCT00904878 |
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Recruitment Status :
Recruiting
First Posted : May 20, 2009
Last Update Posted : October 11, 2018
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Sponsor:
University of California, San Francisco
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of California, San Francisco
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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 15 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.
| 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 2019 |
| Estimated Study Completion Date : | June 2019 |
Primary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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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 |
Study Population
Female patients with confirmed IBD diagnoses who are pregnant
Criteria
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
Information from the National Library of Medicine
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
Contacts
| Contact: Jessica Lim | 415-885-3734 | jessica.lim@ucsf.edu | |
| Contact: Michael Berman | 415-514-8947 | michael.berman@ucsf.edu |
Locations
| 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 | |
Sponsors and Collaborators
University of California, San Francisco
Crohn's and Colitis Foundation
Investigators
| Principal Investigator: | Uma Mahadevan, MD | University of California, San Francisco |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00904878 History of Changes |
| 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: | October 11, 2018 |
| Last Verified: | October 2018 |
Keywords provided by University of California, San Francisco:
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pregnant IBD patients |
Additional relevant MeSH terms:
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Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |