The Savella Pregnancy Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females exposed to Savella during pregnancy
- •Willing to provide verbal consent
- •18 y/o, US citizen
排除标准
- •Under 18 y/o
- •Females not pregnant, not exposed to Savella
结局指标
主要结局
The primary objective is to estimate the prevalence of major congenital anomalies among off-springs of women exposed to Savella during pregnancy.
时间窗: January 2017
次要结局
- Estimate the prevalence of spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and adverse pregnancy outcomes.(January 2017)