Comparison of Efficacy of Surgical Interventions (Balloon Tamponade Versus B-lynch Suture) to Prevent Postpartum Hemorrhage in Patients With Placenta Previa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean blood loss
研究概览
简要总结
Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.
详细描述
After approval from hospital ethical committee, patients fulfilling the inclusion & exclusion criteria were recruited after taking informed written consent for surgery. Patients were allocated to group A and B using computer generated random sample allocation.
In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters.
In group B, B-lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Late Third Trimester pregnancy (35+ weeks to 39 weeks)
- •Placenta Previa confirmed by ultrasonography
- •Elective Caesarean Section.
排除标准
- •Multiple gestation
- •Placenta accreta Spectrum (accrete/increta/percreta)
- •Bleeding diathesis
- •Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
- •Serious medical or surgical diseases.
研究组 & 干预措施
GROUP A
In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.
干预措施: Balloon Tamponade or B-Lynch (Procedure)
GROUP B
In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.
干预措施: Balloon Tamponade or B-Lynch (Procedure)
结局指标
主要结局
Mean blood loss
时间窗: 24 hours post procedure
Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.
次要结局
未报告次要终点
研究者
M. Awais Qarni
Anesthesiologist
CMH Jhelum