Betaseron Pregnancy Registry
Completed
Conditions studied: Birth Defects, Pregnancy Complications, Multiple Sclerosis
In brief
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).
Key facts
- Study ID
- NCT00317564
- Run by
- Syneos Health
- People needed
- 113
- Starts
- 2006-04-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2018-12-12
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- The subjects must meet the following criteria for registration:
- Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
- Diagnosed with MS prior to or during the current pregnancy
- Exposed to Betaseron® on or after the first day of the patient's last menstrual period
- Provide verbal consent to participate in the Registry
- Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
Where it is running
- INC Research — Wilmington, North Carolina, United States
Full record on ClinicalTrials.gov
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