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

NCT ID: NCT00904878

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2028-06-30

Brief Summary

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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

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

Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Crohn's and Colitis Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uma Mahadevan, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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

San Francisco, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Lim

Role: CONTACT

415-885-3734

Nicole Arima

Role: CONTACT

415-514-8947

Facility Contacts

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Jessica Lim

Role: primary

415-885-3734

References

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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.

Reference Type DERIVED
PMID: 33227283 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29857090 (View on PubMed)

Other Identifiers

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CCFA pregnancy Registry

Identifier Type: OTHER

Identifier Source: secondary_id

CCFA Pregnancy Registry

Identifier Type: -

Identifier Source: org_study_id

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