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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 January 2016 by University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904878
First Posted: May 20, 2009
Last Update Posted: January 6, 2016
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.
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of California, San Francisco
  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 4 years from birth.

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 2014 ]

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 2014 ]

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

Estimated Enrollment: 1500
Study Start Date: August 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Locations
United States, California
Please Contact Natalia Wagner 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: Natalia Wagner    415-885-3734    natalia.wagner@ucsf.edu   
Principal Investigator: Uma Mahadevan, MD         
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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00904878     History of Changes
Other Study ID Numbers: CCFA Pregnancy Registry
CCFA pregnancy Registry ( Other Identifier: Crohn's and Colitis Foundation of America )
First Submitted: May 18, 2009
First Posted: May 20, 2009
Last Update Posted: January 6, 2016
Last Verified: January 2016

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

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