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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of California, San Francisco

About this trial

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 18 years from birth.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy

Disqualifiers

Pregnant female patients younger than 18 years of age

Confirmed multiple gestation

Trial population

Female patients with confirmed IBD diagnoses who are pregnant

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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 outcomes

1

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 outcomes

1

Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD

Time frame
December 2014

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Crohn's and Colitis Foundation

Collaborator