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

NCT00904878 | Recruiting

• 2 other identifiers: CCFA Pregnancy RegistryCCFA pregnancy Registry
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

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 18 years from birth.

Conditions

Inflammatory Bowel Disease

Keywords

pregnant IBD patients

Outcome Measures

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

  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

  December 2014

Other Outcomes (1)

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

  December 2014

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with confirmed IBD diagnoses who are pregnant

You may qualify if:

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

You may not qualify if:

• Pregnant female patients younger than 18 years of age
• Confirmed multiple gestation

Sponsors & Collaborators

• University of California, San Francisco: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (2)

Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations

San Francisco, California, 94115, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94115, United States

RECRUITING

Related Publications (2)

• Mahadevan U, Long MD, Kane SV, Roy A, Dubinsky MC, Sands BE, Cohen RD, Chambers CD, Sandborn WJ; Crohn's Colitis Foundation Clinical Research Alliance. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease. Gastroenterology. 2021 Mar;160(4):1131-1139. doi: 10.1053/j.gastro.2020.11.038. Epub 2020 Nov 21.

  PMID: 33227283 DERIVED

• 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.

  PMID: 29857090 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Uma Mahadevan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Lim

CONTACT

415-885-3734; jessica.lim@ucsf.edu

Nicole Arima

CONTACT

415-514-8947; nicole.arima@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: August 1, 2007
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (2)