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NCT00904878 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00904878
Other study ID # CCFA Pregnancy Registry
Secondary ID CCFA pregnancy R
Status Recruiting
Phase
First received
Last updated
Start date August 2007
Est. completion date June 2025

Study information
Verified date July 2023
Source University of California, San Francisco
Contact Jessica Lim
Phone 415-885-3734
Email jessica.lim@ucsf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1500
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations San Francisco California
United States University of California San Francisco San Francisco California

Sponsors (2)
Lead Sponsor Collaborator
University of California, San Francisco Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD December 2014
Primary 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 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
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