The Savella Pregnancy Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Syneos Health
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy.
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The Savella Pregnancy Registry is a US based registry designed to monitor pregnancies exposed to Savella (milnacipran HCI). This is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to Savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. Live offspring are followed from birth until age one. The Savella Pregnancy Registry is sponsored by AbbVie (formerly Actavis PLC, Forest Laboratories Inc., and Allergan) and managed by Syneos Health.
Detailed Description
Registry enrollment is voluntary and initiated by pregnant patients or their healthcare providers (HCP). Patient-initiated reports must be verified by the HCP. Enrollment should occur as early in pregnancy as possible, preferably before any prenatal testing has occurred; however, enrollment at any time during pregnancy is allowed. Near the estimated date of delivery, the Registry prompts the HCP to provide pregnancy outcome data. If a live birth is reported, the Registry conducts follow-up with the infant's HCP at outcome, 4 months, and 12 months of age. If a birth defect is indicated, the Registry requests additional targeted follow-up information from the HCP. Data are collected on exposure to Savella, potential confounding factors, pregnancy outcome, and pediatric outcome for all live born babies. Cases are reviewed and classified according to type of birth defects. Adverse event cases are forwarded to Allergan.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Females exposed to Savella during pregnancy
- •Willing to provide verbal consent
- •18 y/o, US citizen
Exclusion Criteria
- •Under 18 y/o
- •Females not pregnant, not exposed to Savella
Outcomes
Primary Outcomes
The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy.
Time Frame: January 2017
Secondary Outcomes
- Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes.(January 2017)