Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 主要终点
- Total measured blood loss
研究概览
简要总结
To determine if a balloon tamponade catheter filled with cold saline is more effective than a catheter filled with room temperature saline in controlling post partum hemorrhage.
详细描述
When post partum hemorrhage occurs one mode of therapy is to place a balloon tamponade catheter into the uterus to compress the bleeding vessels. When this mode of therapy has been chosen by the attending physician the patient will be randomized to either the room temperature arm (control) or the cold arm (study). The balloon catheter is placed through the vagina into the uterus and inflated using normal saline; room temperature for the control group and approximately 32 degrees F for the study group. Traction is placed on the catheter to tamponade the vessels in the lower uterine segment. Blood from the uterus passes through a central lumen of the balloon and will be collected and measured. Total measured blood loss for each group will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 18-45 years old who have just delivered they baby vaginally who now have uncontrolled bleeding from their uteri
排除标准
- •anyone outside of the specified age group
- •anyone who declines to participate in the study
研究组 & 干预措施
Room temperature arm
Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at room temperature.
干预措施: Cold Bakri Balloon (Device)
Cold arm
Intervention: The balloon catheter will be placed through the vagina into the uterus and inflated using normal saline at approximately 32 degrees F for the study group.
干预措施: Cold Bakri Balloon (Device)
结局指标
主要结局
Total measured blood loss
时间窗: time frame is approximately 24 hours, until the balloon catheter is removed from the uterus
次要结局
未报告次要终点
