Inflammatory Bowel DiseaseNCT00904878
A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jun 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients with confirmed IBD diagnoses who are pregnant
Who may be able to join
- Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
Who cannot join
- Pregnant female patients younger than 18 years of age
- Confirmed multiple gestation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations
San Francisco, California, 94115
- Recruiting
University of California San Francisco
San Francisco, California, 94115
Jessica Lim, 415-885-3734, jessica.lim@ucsf.edu
Uma Mahadevan, MD
About this study
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.
Read the detailed description
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- pregnant IBD patients
- Medical subject headings
- Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2014
Secondary outcomes (1)
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
Measured: December 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startAug 2007
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Uma Mahadevan, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904878
- Sponsor's protocol ID
- CCFA Pregnancy Registry
- Other IDs
- CCFA pregnancy Registry
- Status last verified
- Aug 2026
- First submitted
- 18 May 2009
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33227283Matro 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.
PubMed 29857090