Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.
详细描述
In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol.
排除标准
- •A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease.
- •B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins.
- •F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.
研究组 & 干预措施
Misoprostol
60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
干预措施: Misoprostol (Drug)
Placebo
60 minutes before the surgery 2 tablets of placebo tablets inserted rectally
干预措施: Placebo (Drug)
结局指标
主要结局
Blood loss
时间窗: 8 months
amount of intra-operative blood loss
次要结局
- postoperative hemoglobin level(8 months)
研究者
Waleed El-khayat
Assistant Professor of Obstetrics & Gynecology
Cairo University