跳至主要内容
临床试验/NCT02735733
NCT02735733撤回不适用

Does Cold Saline Used to Inflate a Balloon Tamponade Catheter More Significantly Reduce Blood Loss From Postpartum Hemorrhage Than Room Temperature Saline?

Baylor Research Institute0 个研究点目标入组 50 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

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

Active Comparator

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

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