Betaseron Pregnancy Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00317564|
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : December 9, 2013
|Condition or disease||Phase|
|Birth Defects Pregnancy Complications Multiple Sclerosis||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|Official Title:||Betaseron Pregnancy Registry|
|Study Start Date :||April 2006|
|Primary Completion Date :||April 2012|
|Study Completion Date :||June 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|