Betaseron Pregnancy Registry

NCT00317564 | Completed DMC

• 1 other identifier: 308740
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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

Birth Defects; Pregnancy Complications; Multiple Sclerosis

Keywords

Birth Defects; High Risk Pregnancy; Multiple Sclerosis

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

US only

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)

Sponsors & Collaborators

• Syneos Health: lead
• Bayer: collaborator

Study Sites (1)

INC Research

Wilmington, North Carolina, 28405, United States

Location

Related Publications (1)

• Coyle PK, Sinclair SM, Scheuerle AE, Thorp JM Jr, Albano JD, Rametta MJ. Final results from the Betaseron (interferon beta-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events. BMJ Open. 2014 May 12;4(5):e004536. doi: 10.1136/bmjopen-2013-004536.

  PMID: 24821713 DERIVED

MeSH Terms

Conditions

Congenital Abnormalities; Pregnancy Complications; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jessica Albano, PhD, MS

  Syneos Health

  PRINCIPAL INVESTIGATOR

• Vicki Poon, MPH

  Bayer

  STUDY DIRECTOR

• Mark Rametta, D.O., FACOI, FACP

  Bayer

  STUDY DIRECTOR

• Karen Maloney Marini

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (1)