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

Clinical Trial Details

This research study is for pregnant women who have either Crohn’s disease or ulcerative colitis.

The study is being conducted to determine whether the rates of birth defects, miscarriages, premature births and other outcomes in women with inflammatory bowel disease (IBD) taking azathioprine/6MP or anti-TNF therapy (Remicade, Humira, Cimzia) are different from those among women with IBD who are taking these medications. Little is known about the effects of these medications on pregnant women and their babies. This information will be valuable in guiding the therapy of women with Crohn’s disease or ulcerative colitis who wish to have children while receiving therapy for their illness.

Study participants will be asked to complete questionnaires when they enter the study, during each trimester of their pregnancy, at delivery and at 4, 9, and 12 months after the birth of their baby. 

Key Eligibility: 
  • Pregnant women with Crohn's disease or ulcerative colitis
  • Age 18 to 50

Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

0802009666

Status

Open to Enrollment

Sponsor