NCT01892215已完成不适用
Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad. A Randomized, Controlled Trial.
Saint Thomas Hospital, Panama1 个研究点 分布在 1 个国家目标入组 839 人开始时间: 2012年10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
- 839
- 试验地点
- 1
- 主要终点
- Blood loss (hemoglobin level)
研究概览
简要总结
Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancies
- •Gestational age: 34 weeks or more
- •Delivery by cesarean section
- •Presurgical hemoglobin > 10.5 g/dL
排除标准
- •Two or more previous cesarean sections
- •History of uterine rupture in a previous pregnancy
- •History of myomectomy
- •History of abdominal trauma with an uterine lesion
- •Blood dyscrasia
- •Multiple pregnancy
- •Placenta previa
- •Abruptio placenta
- •Stillbirth
- •Sharp uterine expansion
结局指标
主要结局
Blood loss (hemoglobin level)
时间窗: 72 hours
Difference in hemoglobin level between 24 hours pre-surgery and the hemoglobin level before leaving the hospital.
次要结局
- Unintented extension of uterine incision(72 hours)
- Surgical complications(72 hours)
- Hematoma formation(72 hours)
- Need for transfusion(72 hours)
研究者
Osvaldo A. Reyes T.
Coordinator of Research
Saint Thomas Hospital, Panama
研究点 (1)
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