NCT05752513招募中不适用
Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Amount of blood loss
研究概览
简要总结
Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups
- Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
- Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.
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
- Double (Investigator, Outcomes Assessor)
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
- •Age: reproductive age.
- •Pregnant with singleton living fetus.
- •Previous one or more cesarean sections.
- •Gestational age: > 34 weeks.
- •Elective or non-emergency cesarean sections.
- •Preoperative hemoglobin more than 9.5 gm/dl.
排除标准
- •Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.
研究组 & 干预措施
Group 1
Placebo Comparator
18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta
干预措施: early bladder dissection (Procedure)
Group 2
Experimental
18 pregnant women scheduled for bladder last cesarean hysterectomy
干预措施: Late bladder dissection (Procedure)
结局指标
主要结局
Amount of blood loss
时间窗: during cesarean hysterectomy
次要结局
- Operative time(during cesarean hysterectomy)
- bladder injury(during cesarean hysterectomy)
- ureteric injury(during cesarean hysterectomy)
- Need for massive blood transfusion(during cesarean hysterectomy)
研究者
研究点 (1)
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