The Savella Pregnancy Registry
Megadott ok: Per the FDA, there is no regulatory requirement to continue this registry.
A legfontosabb adatok
- Hol
- Raleigh (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- Syneos HealthRaleigh, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Syneos Health
- Azonosító
- NCT01026077
- A regiszteradat frissítve
- 2025. január 8.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: Females exposed to Savella during pregnancy; Willing to provide verbal consent; 18 y/o, US citizen.
Kizáró feltételek: Male; Under 18 y/o; Females not pregnant, not exposed to Savella.