A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease
Observational · No treatment assigned · 2 sites · University of California, San Francisco
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 45
- Women only
Some of the main requirements, copied from the record:
- Female patients with confirmed IBD diagnoses who are pregnant and taking immunosuppressants and/or biologic therapy
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 1500 participants are expected to take part.
- Start date: 2007-08.
- Main results expected around 2028-06 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in United States.
Main thing being measured
- 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… (December 2014)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | University of California, San Francisco |
| Collaborators | Crohn's and Colitis Foundation |
| Enrollment | 1500 (estimated) |
| Start date | 2007-08 |
| Primary completion (est.) | 2028-06 |
| First posted | 2009-05-20 |
| Last updated | 2026-08-11 |
| Official title | A Multicenter National Prospective Study of Pregnancy and Neonatal Outcomes in Women With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT00904878 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Please Contact Jessica Lim For Further Information Regarding Other Sites' Locations | San Francisco, California | United States | Recruiting |
| University of California San Francisco | San Francisco, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.