NCT04518150Unknown不适用
Clinical Outcomes of Combined Bilateral Uterine Artery Ligation and Bakri Balloon Tamponade During Cesarean Section in Patients With Placenta Previa: a Randomized Controlled Trial
Aswan University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- mean Blood loss after placental separation
研究概览
简要总结
This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa
详细描述
Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.
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 (Participant)
盲法说明
single blind randomized controlled trial
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
- •women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
排除标准
- •patients with the high possibility of morbid adherent placenta
- •those presented with severe antepartum hemorrhage
- •Patients with cardiac, hepatic, renal, or thromboembolic disease;
- •patient refuses to consent
结局指标
主要结局
mean Blood loss after placental separation
时间窗: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
次要结局
- The number of participant needed for blood transfusion(24 hours)
- Number of Participants with postpartum hemorrhage(24 hours)
研究者
hany farouk
A Professor
Aswan University Hospital
研究点 (2)
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