Recruiting

Inflammatory Bowel Disease

Sponsor:

UCLA

Code:

NCT00904878

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Study Details

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 18 years from birth.

Conditions

Inflammatory Bowel Disease

Study ID

NCT00904878

Start date

Aug, 2007

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jessica Lim

415-885-3734jessica.lim@ucsf.edu

Nicole Arima

415-514-8947nicole.arima@ucsf.edu

Locations

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

Contacts

Jessica Lim

415-885-3734jessica.lim@ucsf.edu

Principal Investigator:

Uma Mahadevan, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • pregnant IBD patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-11.