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Betaseron Pregnancy Registry

NCT00317564 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 113

Last updated 2018-12-12

No results posted yet for this 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).

Conditions

Sponsors & Collaborators

Principal Investigators

  • Jessica Albano, PhD, MS · Syneos Health

  • Vicki Poon, MPH · Bayer

  • Mark Rametta, D.O., FACOI, FACP · Bayer

  • Karen Maloney Marini · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317564 on ClinicalTrials.gov