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NCT Number: NCT00904878

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations, San Francisco, California, United States

Loading trial locations.

About this study

All pregnant women with IBD diagnosis who are taking biologics medicines and immunosuppressants will be entered in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Lim

CONTACT

[email protected]

415-885-3734

Nicole Arima

CONTACT

[email protected]

415-514-8947

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Crohn's and Colitis Foundation

Registry information

Important dates

Study start
2007
Primary completion
2028
Study completion
2028
First posted
May 20, 2009
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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