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Trial record 1 of 1 for:    NCT00904878
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A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT00904878
Recruitment Status : Recruiting
First Posted : May 20, 2009
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date May 18, 2009
First Posted Date May 20, 2009
Last Update Posted Date October 11, 2018
Study Start Date August 2007
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2014)
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 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00904878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 14, 2014)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 14, 2014)
Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD [ Time Frame: December 2014 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Official Title A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
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 15 years from birth.
Detailed Description All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female patients with confirmed IBD diagnoses who are pregnant
Condition Inflammatory Bowel Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Matro R, Martin CF, Wolf D, Shah SA, Mahadevan U. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterology. 2018 Sep;155(3):696-704. doi: 10.1053/j.gastro.2018.05.040. Epub 2018 May 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 26, 2015)
1500
Original Estimated Enrollment
 (submitted: May 19, 2009)
660
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jessica Lim 415-885-3734 jessica.lim@ucsf.edu
Contact: Michael Berman 415-514-8947 michael.berman@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00904878
Other Study ID Numbers CCFA Pregnancy Registry
CCFA pregnancy Registry ( Other Identifier: Crohn's and Colitis Foundation of America )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Crohn's and Colitis Foundation
Investigators
Principal Investigator: Uma Mahadevan, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2018