NCT01242384已完成4 期
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
Maternal-Infantil Vall d´Hebron Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Spontaneous delivery before 34 completed weeks
研究概览
简要总结
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimal age of 18 years
- •Episode of threatened preterm labour
排除标准
- •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
- •Spontaneous rupture of membranes at the time of randomization
- •Cervical cerclage in situ
- •Active vaginal bleeding
- •Placenta previa
- •Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).
结局指标
主要结局
Spontaneous delivery before 34 completed weeks
时间窗: Each 6 months
次要结局
- Neonatal morbidity(Each 6 months)
- Birth weight(Each 6 months)
- Preterm birth before 37 weeks or 28 weeks(Each 6 months)
- Fetal-Neonatal Death(Each 6 months)
- Rupture of membranes before 34 weeks(Each 6 months)
- Maternal adverse effects(Each 6 months)
- Hospitalisation for threatened preterm labour(Each 6 months)
研究者
Maria Goya, MD, PhD
PhD
Maternal-Infantil Vall d´Hebron Hospital
研究点 (2)
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