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NCT01086059 · ClinicalTrials.gov registry record
OTIS Humira Pregnancy Registry
A clinical trial, sponsored by University of California, San Diego.
- Completed
- Registry status
- 944
- Enrollment target
NCT01086059: Completed study, sponsored by University of California, San Diego.
NCT01086059 is a clinical trial that has completed, run by University of California, San Diego. The registered enrollment target is 944 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086059 has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- 944 participants
- Enrollment target
Study Summary
The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects that are visible at birth, as well as, more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Primary Outcome
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 944 participants |
| Start Date | 2003-11 |
| Est. Completion | 2019-10 |
What the finished NCT01086059 record still lists
NCT01086059 is an observational study that tracks outcomes without assigning an intervention. The registered 944 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01086059 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01086059 about?
NCT01086059 is a clinical study titled "OTIS Humira Pregnancy Registry". The purpose of the OTIS Autoimmune disease in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it i...
What is the current status of trial NCT01086059?
This trial is currently completed. The enrollment target is 944 participants. The study started on 2003-11. Estimated completion is 2019-10.
Who is sponsoring clinical trial NCT01086059?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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