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临床试验/NCT03308643
NCT03308643已完成4 期

Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Blood loss during surgery

研究概览

简要总结

To evaluate the effects of oxytocin infusion during abdominal myomectomy.

详细描述

Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20% of the abdominal myomectomy cases might require blood transfusion because of the nature of the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal myomectomy we decide to conduct this randomized study.

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
Double (Participant, Investigator)

盲法说明

Randomization will be performed by an online software and the list will be given to anesthesiologist so that neither the surgeon nor patient will know which intervention was performed. Randomized cards will be in sealed envelopes and will be open by anesthesiologist at the time of surgery.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-50
  • Patients who are candidate for abdominal myomectomy

排除标准

  • History of previous myomectomy.
  • Suspected malignancy
  • Patients with preoperative anemia
  • Patients using hormonal treatments before the surgery.

研究组 & 干预措施

Oxytocin infusion

Experimental

Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia.

干预措施: saline (Other)

结局指标

主要结局

Blood loss during surgery

时间窗: 2 hours

estimated blood loss during the surgery measured by aspiration fluid.

次要结局

  • Blood loss after abdominal myomectomy(1 hour postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Aslan Cetin

Attending physician,ObGyn

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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