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NCT00317564 · ClinicalTrials.gov registry record
Betaseron Pregnancy Registry
A clinical trial, sponsored by Syneos Health.
- Completed
- Registry status
- 113
- Enrollment target
NCT00317564: Completed study, sponsored by Syneos Health.
NCT00317564 is a clinical trial that has completed, run by Syneos Health. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00317564 has completed, sponsored by Syneos Health.
- COMPLETED
- Registry status
- 113 participants
- Enrollment target
Study Summary
This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval \& Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2006-04 |
| Est. Completion | 2012-06 |
What the finished NCT00317564 record still lists
NCT00317564 is an observational study that tracks outcomes without assigning an intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00317564 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00317564 about?
NCT00317564 is a clinical study titled "Betaseron Pregnancy Registry". This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an inc...
What is the current status of trial NCT00317564?
This trial is currently completed. The enrollment target is 113 participants. The study started on 2006-04. Estimated completion is 2012-06.
Who is sponsoring clinical trial NCT00317564?
This trial is sponsored by Syneos Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
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