A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Blood loss in millilitres
研究概览
简要总结
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.
详细描述
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
排除标准
- •patients who have had previous myomectomy or previous pelvic surgery.
- •patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
- •patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
研究组 & 干预措施
Misoprostol + vasopressin, Vasopressin
Misoprostol 400ug given rectally one hour before surgery.
干预措施: Misoprostol + vasopressin (Drug)
Misoprostol + vasopressin, Vasopressin
Misoprostol 400ug given rectally one hour before surgery.
干预措施: Vasopressin (Drug)
结局指标
主要结局
Blood loss in millilitres
时间窗: At the time of surgery
次要结局
- A change in hemoglobin grams per decilitre(At baseline and 24hours after surgery)
研究者
Dr Sharifa Frederick
Doctor
University Hospital of the West Indies