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临床试验/NCT02672891
NCT02672891已完成不适用

Intrauterine Balloon Tamponade in the Management of Postpartum Hemorrhage in a Low Resource Setting

Menoufia Obstetrics and Gynecology Group2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
control uterine bleeding (normal lochia).

研究概览

简要总结

Intrauterine balloon tamponade in the management of postpartum hemorrhage in the obstetrics emergency ward in menoufiya university hospitals as a low resource setting.Guidelines for the management of postpartum hemorrhage involve a stepwise approach including the exclusion of retained products and genital tract trauma. Uterine atony, which is the most common cause, is dealt with uterine rubbing and various uterotonic agents. Among the new modalities introduced to arrest the bleeding is the uterine tamponade using various balloons and catheters. The condom catheter uses a sterile rubber catheter fitted with a condom for uterine tamponade .

详细描述

Objectives: To evaluate the outcome of uterine balloon tamponade using condom-catheter in the management of primary postpartum hemorrhage (PPH).

Material and Methods

Prospective observational study included 50 women with primary postpartum hemorrhage unresponsive to uterotonics and bimanual compression, was conducted at the department of Obstetrics &Gynecology, Menoufia University Hospital, Egypt. Clinical assessment, laboratory investigations and intrauterine condom catheter were applied to all patients. The primary outcome was the success of the balloon to stop bleeding, maternal complications were assessed as secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • women with primary postpartum hemorrhage ( defined as >500 ml estimated blood loss after vaginal delivery or >1000 ml after cesarean delivery)in the first 24 h , unresponsive to uterotonics and bimanual compression were enrolled

排除标准

  • Patients with traumatic PPH, retained placenta, coagulopathy and severe systemic diseases were excluded from the study

结局指标

主要结局

control uterine bleeding (normal lochia).

时间窗: 30 minutes

次要结局

  • Maternal complications (minor as fever and pain or major as blood transfusion, peripartum hysterectomy)(24 hours)
  • Maternal complications (admission to intensive care unit (ICU))(24 hours)
  • Maternal complications (mortality)(24 hours)

研究者

发起方
Menoufia Obstetrics and Gynecology Group
申办方类型
Other
责任方
Sponsor

研究点 (2)

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