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A Study of Pregnancy and Neonatal Outcomes in Women with Inflammatory Bowel Disease Who Took Biologics

Overview

About this study

This study is 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 biologic therapy (Remicade®, Humira®, Cimzia™, Tysabri®, or Stelara®) are different from those among IBD - affected women not taking these medications.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Female patients with confirmed IBD diagnoses who are pregnant and exposed to a biologic agent with or without immunomodulators anytime from 3 months prior to their last menstrual period to delivery

Exclusion Criteria:

  • Pregnant female patients younger than 18 years of age

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sunanda Kane, M.D.

Closed for enrollment

Contact information:

Brenda Becker CCRP

(507) 266-0111

Becker.Brenda1@mayo.edu

More information

Publications

Publications are currently not available

More about research at Mayo Clinic

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CLS-20151288

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