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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904878
Recruitment Status : Recruiting
First Posted : May 20, 2009
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease
Inflammatory Bowel Disease

Detailed Description:
All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Study Start Date : August 2007
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: December 2014 ]

Other Outcome Measures:
  1. Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD [ Time Frame: December 2014 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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 and taking immunosuppressants and/or biologic therapy

Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age
  • Confirmed multiple gestation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904878


Contacts
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Contact: Jessica Lim 415-885-3734 jessica.lim@ucsf.edu
Contact: Karan Bhatia 415-353-1446 karan.bhatia@ucsf.edu

Locations
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United States, California
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
Contact: Jessica Lim    415-885-3734    jessica.lim@ucsf.edu   
Principal Investigator: Uma Mahadevan, MD         
Sponsors and Collaborators
University of California, San Francisco
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00904878    
Other Study ID Numbers: CCFA Pregnancy Registry
CCFA pregnancy Registry ( Other Identifier: Crohn's and Colitis Foundation of America )
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Keywords provided by University of California, San Francisco:
pregnant IBD patients
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis