Clinical trial NCT00904878: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Official title: A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease
Keywords: pregnant IBD patients
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Foundation
First posted: 2009-05-20
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with confirmed IBD diagnoses who are pregnant

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: December 2014
Secondary outcomes:
measure: 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
timeFrame: December 2014
Other outcomes:
measure: Determine whether breastfeeding impacts developmental delay, growth and infectious complications in children born to women with IBD
timeFrame: December 2014
Locations:
city: San Francisco
country: United States
facility: Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Uma Mahadevan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.