Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean intraoperative blood loss in both groups
研究概览
简要总结
Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach
详细描述
According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient provisionally diagnosed with leiomyoma of uterus with less than 10 cm diameter
- •Patient undergoing myomectomy, both open and laparoscopic approach
- •Patient aged 25 - 50 years
- •Patient able to give free and informed consent and who agrees to participate bu signing the consent form
- •Patient able to speak and understand Thai
- •Patient able to complete the questionnaire
排除标准
- •Patient who was pathologically diagnosed apart from leiomyoma
- •Patient with leiomyoma FIGO type 0
- •Patient who has medical conditions that increase bleeding tendency, such as thrombocytopenia, coagulopathy, renal insufficiency, uncontrolled diabetes mellitus, taking antiplatelets or anticoagulants less than 7 days prior the surgery
- •Patient who takes prostaglandin analogs and/or antagonists (NSAIDS) less than 7 days prior the surgery.
- •Patient who may take higher risks of misoprostol adverse effect such as hypertension, ischemic heart disease, glaucoma, asthma
- •Patient who had and allergic reaction to misoprostol or vitamin B6
研究组 & 干预措施
A
Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
干预措施: Rectal Misoprostol (Drug)
B
Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
干预措施: Placebo (Drug)
结局指标
主要结局
Mean intraoperative blood loss in both groups
时间窗: Within 3 hours
次要结局
- Incidence of unplanned operation(within 72 hours)
- Incidence of adverse events(within 72 hours)
- Mean difference of hemoglobin(within 24 hours)
- Incidence of blood transfusion(within 72 hours)