NCT01130324撤回不适用
VIBATIV (Telavancin Hydrochloride) Pregnancy Exposure Registry
Cumberland Pharmaceuticals1 个研究点 分布在 1 个国家开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy
研究概览
简要总结
The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients who were exposed to VIBATIV at any time during pregnancy
- •Outcome of pregnancy is unknown at the time of enrollment
排除标准
- 未提供
研究组 & 干预措施
VIBATIV treated pregnant women
Women treated with telavancin (any dose or duration) during pregnancy.
干预措施: VIBATIV (Drug)
结局指标
主要结局
Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy
时间窗: Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date
次要结局
- Effect of fetal exposure to VIBATIV on pregnancy outcomes(Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.)
- Fetal/neonatal outcomes(Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.)
- Infant development and milestones through 12 months of age(Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.)
研究者
研究点 (1)
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