2023-503220-76-01招募中4 期
Prednisolone administration in women with unexplained REcurrent MIscarriages
Leiden University Medical Center12 个研究点 分布在 1 个国家目标入组 490 人开始时间: 2023年10月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 12
- 主要终点
- Last study subject has completed last visit and all data is gathered
研究概览
简要总结
The primary aim of the PREMI trial is to assess the effect of prednisolone administration during early pregnancy in women with unexplained recurrent miscarriages in comparison to the use of a placebo, specifically focusing on the live birth rate as the primary outcome measure.
研究设计
- 分配方式
- Randomized
- 主要目的
- Prednisolone administration in women with REcurrent MIscarriages
- 盲法
- Double (Carer, Subject, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Two or more miscarriages (mola and ectopic pregnancies excluded)
- •No underlying cause was found for miscarriages after examination
排除标准
- •Diabetes with medication
- •Previous enrollment/ participation in PREMI trial
- •Contraindication for the use of glucocorticosteroids
- •Use of medication that interferes with prednisolone (see protocol for list)
- •Instable or exacerbation of auto-immune disease
- •Use of immune suppressing medication (for any reason)
- •Participation or enrollment in other interventional trial for recurrent miscarriages
结局指标
主要结局
Last study subject has completed last visit and all data is gathered
Last study subject has completed last visit and all data is gathered
次要结局
- DSMB advises to stop trial (for feasibility, slow inclusion rate, safety concerns etc.)
研究者
Department of gynecology and obstetrics
Scientific
Leiden University Medical Center
研究点 (12)
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