Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317564
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2006-04-21
Brief Title:
Betaseron Pregnancy Registry
Sponsor:
Syneos Health
Organization:
Syneos Health
Study Overview
Official Title:
Betaseron Pregnancy Registry
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational registration and follow-up study of women exposed to Betaseron at the time of conception ie any time from the first day of the last menstrual period andor 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
Detailed Description:
Because informed consent is required the Registration process must be initiated by the patient An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly Once an eligible subject provides consent and permission to obtain information from her HCP the Registry will contact the obstetric HCP and obtain information on demographics history of previous pregnancies maternal risk factors pregnancy outcome and neonatal health Data will be collected from the maternal HCP at enrollment during the second trimester around week 20 and at outcome Data on live born infants will be collected from the pediatrician at 4 months of age If a birth defect is reported targeted follow-up may be conducted
NOTE This study has previously been posted by Berlex Inc which has since been renamed to Bayer HealthCare Pharmaceuticals Inc Bayer HealthCare Pharmaceuticals Inc is the sponsor of this pregnancy registry
NOTE This study has previously been posted by Berlex Inc which has since been renamed to Bayer HealthCare Pharmaceuticals Inc Bayer HealthCare Pharmaceuticals Inc is the sponsor of this pregnancy registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None