Betaseron Pregnancy Registry
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Women's Studies, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/14/2018 |
| Start Date: | April 2006 |
| End Date: | June 2012 |
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).
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).
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.
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.
Inclusion Criteria:
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)
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