The Savella Pregnancy Registry
Reason given: Per the FDA, there is no regulatory requirement to continue this registry.
Key facts
- Where
- Raleigh, United StatesSee the site
Where in United States
- Syneos HealthRaleigh, United StatesNo longer taking part
Trial details
- Who runs it
- Syneos Health
- Trial code
- NCT01026077
- Record updated
- 8 January 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Females exposed to Savella during pregnancy; Willing to provide verbal consent; 18 y/o, US citizen.
Exclusion: Male; Under 18 y/o; Females not pregnant, not exposed to Savella.