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 : October 11, 2018

See Contacts and Locations

Sponsor:

Collaborator:

Crohn's and Colitis Foundation

Information provided by (Responsible Party):

University of California, San Francisco

Study Description

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.

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

Layout table for study information

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 2019
Estimated Study Completion Date :	June 2019

Groups and Cohorts

Outcome Measures

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 ]

Eligibility Criteria

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.

Layout table for eligibility information

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

Layout table for location contacts

Contact: Jessica Lim	415-885-3734	jessica.lim@ucsf.edu
Contact: Michael Berman	415-514-8947	michael.berman@ucsf.edu

Locations

Layout table for location information

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

Layout table for investigator information

Principal Investigator:	Uma Mahadevan, MD	University of California, San Francisco

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal 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 Posted:	May 20, 2009 Key Record Dates
Last Update Posted:	October 11, 2018
Last Verified:	October 2018

Keywords provided by University of California, San Francisco:


pregnant IBD patients

Additional relevant MeSH terms:

Layout table for MeSH terms

Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis

To Top