EUCTR2011-000105-53-CZ进行中（未招募）1 期
A Prospective Follow-Up Study of Children Aged 23 to 25 months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
KV Pharmaceutical Co.0 个研究点目标入组 375 人开始时间: 2012年7月27日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 375
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each subject must meet the following criteria to be enrolled in this study:
- •1.Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.
- •2.During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
- •3.Children between 22 and 25 months of age adjusted for gestational age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 375
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •1.There is no parent/legal guardian available to sign an informed consent.
- •2.Born to women who are unblinded to study group assignment.
研究者
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