NCT00193674已完成3 期
Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial
Abbott Products3 个研究点 分布在 2 个国家目标入组 71 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 3
- 主要终点
- Cytokine ratio IFN/IL-10
研究概览
简要总结
The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Dydrogesterone (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Cytokine ratio IFN/IL-10
时间窗: 14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)
次要结局
- Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone(First trimester of pregnancy)
研究者
研究点 (3)
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