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

This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00904878
First received: May 18, 2009
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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 one year from birth. We are looking for 660 pregnant women to enroll in the duration of 3 years.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: December 2013 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD [ Time Frame: December 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female patients with confirmed IBD diagnoses who are pregnant

Criteria

Inclusion Criteria:

  • Female patients with confirmed IBD diagnoses who are pregnant

Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age
  • Confirmed multiple gestation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904878

Contacts
Contact: Yelena Idomsky 415-353-7871 yelena.idomsky@ucsfmedctr.org

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Yelena Idomsky     415-353-7871     yelena.idomsky@ucsfmedctr.org    
Principal Investigator: Uma Mahadevan, MD            
Please Contact Yelena Idomsky For Further Information Regarding Other Sites' Locations Recruiting
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Crohn's and Colitis Foundation
Investigators
Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00904878     History of Changes
Other Study ID Numbers: CCFA Pregnancy Registry
Study First Received: May 18, 2009
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
pregnant IBD patients

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013