A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Recruiting

• Conditions: Inflammatory Bowel Disease

• Registration Number: NCT00904878
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

• Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy

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Exclusion Criteria

• Pregnant female patients younger than 18 years of age
• Confirmed multiple gestation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations; 🇺🇸 San Francisco, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States