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| ID | Type | Description | Link |
|---|---|---|---|
| CCFA pregnancy Registry | Other Identifier | Crohn's and Colitis Foundation of America |
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| Name | Class |
|---|---|
| Crohn's and Colitis Foundation | OTHER |
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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.
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
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| Measure | Description | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD | December 2014 |
Inclusion Criteria:
Exclusion Criteria:
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Female patients with confirmed IBD diagnoses who are pregnant
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Lim | Contact | 415-885-3734 | jessica.lim@ucsf.edu | |
| Nicole Arima | Contact | 415-514-8947 | nicole.arima@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Uma Mahadevan, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations | Recruiting | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33227283 | Derived | Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE, Cohen RD, Chambers CD, Sandborn WJ; Crohn's Colitis Foundation Clinical Research Alliance. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038. Epub 2020 Nov 21. | |
| 29857090 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| University of California San Francisco | Recruiting | San Francisco | California | 94115 | United States |
|
| Derived |
| Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. doi: 10.1053/j.gastro.2018.05.040. Epub 2018 May 30. |