Betaseron Pregnancy Registry
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Betaseron Pregnancy Registry|
|Study Start Date:||April 2006|
|Study Completion Date:||June 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317564
|United States, North Carolina|
|Wilmington, North Carolina, United States, 28405|
|Principal Investigator:||Jessica Albano, PhD, MS||INC Research|
|Study Director:||Vicki Poon, MPH||Bayer|
|Study Director:||Mark Rametta, D.O., FACOI, FACP||Bayer|
|Study Director:||Karen Maloney Marini||Bayer|