Study on pregnancy outcomes in women with inflammatory bowel disease
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
University of California, San Francisco · NCT00904878
This study looks at how inflammatory bowel disease and the medications used to treat it affect pregnancy and baby health in women over many years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of California, San Francisco (other) |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT00904878 on ClinicalTrials.gov |
What this trial studies
This study investigates the pregnancy and neonatal outcomes in women diagnosed with inflammatory bowel disease (IBD) across multiple centers in the United States. It focuses on the effects of medication use and disease activity during pregnancy, specifically among those taking biologics and immunosuppressants. The study aims to gather data over a period of up to 18 years from birth to better understand the implications of IBD on pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a confirmed diagnosis of inflammatory bowel disease who are currently taking immunosuppressants or biologic therapies.
Not a fit: Patients who are younger than 18 years old or those with confirmed multiple gestation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve pregnancy management and outcomes for women with inflammatory bowel disease.
How similar studies have performed: Other studies have explored pregnancy outcomes in women with IBD, suggesting that this area of research is important and has the potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 1 other locations
- Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations — San Francisco, California, United States (RECRUITING)
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Uma Mahadevan, MD — University of California, San Francisco
- Study coordinator: Jessica Lim
- Email: jessica.lim@ucsf.edu
- Phone: 415-885-3734
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammatory Bowel Disease, pregnant IBD patients