17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor
试验速览
- 阶段
- 3 期
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.
The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week.
- •The subject has a short cervical length defined as 25 mm before 24 weeks gestation.
- •A singleton gestation.
排除标准
- •Multifetal pregnancy.
- •The subject has or will have a cervical cerclage in place.
研究组 & 干预措施
1
previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
干预措施: 17 alfa hydroxyprogesterone caproate (Drug)
2
previous preterm delivery, treatment with daily vaginal natural progesterone
干预措施: natural progesterone (Drug)
3
short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.
干预措施: 17 alfa hydroxyprogesterone caproate (Drug)
4
short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
干预措施: vaginal progesterone (Drug)
结局指标
主要结局
efficacy
时间窗: 3 years
次要结局
- comfort of use and consequently of that compliance(3 years)