NCT02694341撤回不适用
Bakri Ballon With or Without Abdominal Traction Stitch in Management of Uterine Bleeding in Cases of Placenta Previa
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
研究概览
简要总结
The Bakri intrauterine balloon can achieve haemostasis in cases of postpartum haemorrhage, including haemorrhage associated with placenta previa by compressing the lower uterine segment.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women delivered and presented with primary atonic PPH
- •Women who accepted to participate
排除标准
- •Traumatic PPH as excluded by examination under anesthesia.
- •With any suspected or clinical evidence of uterine infection
- •Women diagnosed to have preeclampsia or eclampsia after delivery.
- •Women who had DM during pregnancy
- •Women with history of DVT or other thromboembolic complication
- •Women with history of rheumatic heart disease.
- •Women with coagulation defects.
研究组 & 干预措施
Bakri Balloon with abdominal traction stitch
Active Comparator
bakri balloon will be inserted with abdominal traction stitch
干预措施: Abdominal traction stitch (Procedure)
Bakri Balloon with abdominal traction stitch
Active Comparator
bakri balloon will be inserted with abdominal traction stitch
干预措施: Bakri Balloon (Device)
Bakri Balloon without abdominal traction stitch
Experimental
bakri balloon will be inserted with no performance of abdominal traction stitch
干预措施: Bakri Balloon (Device)
结局指标
主要结局
Percentages of failure of Bakri Balloon either rupture of balloon or slippage of balloon.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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