the Effect of Misoprostol on Intra-operative Blood Loss During Myomectomy Operation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- blood loss
研究概览
简要总结
assess the effect of using misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications. Research question Does pre-operative misoprostol affect on intra-operative blood loss during and after myomectomy operation ?. Research hypothesis Pre-operative misoprostol may reduce intra-operative blood loss during and after myomectomy operation .
详细描述
. Type of Study : Prospective double blind randomized placebo controlled clinical trial.
- Study Setting : This study will be conducted in Ain Shams University Maternity hospital.
- Study Period : 6 months
- Study Population : Patients will be recruited in this study those attending gynecology ward at Ain Shams University Maternity hospital who are 25-50 years old with symptomatic uterine myoma
Methodology
All women will be subjected to:
History taking:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal patients aged between 35 to 50 years old.
- •Five or less symptomatic uterine myomas .
- •Maximum diameter of the largest myoma is 6 cm .
- •All myomas are subserous or intramural.
- •Uterine size less than 24 weeks pregnancy
排除标准
- •History of previous surgery.
- •Allergy to Misoprostol.
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Patients who have bleeding disorders.
- •Anemia (Hb < 10g %).
- •Chronic endocrine or metabolic diseases such as Diabetes.
- •Obesity (body mass index > 30 kg/m2).
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
研究组 & 干预措施
misoprostol group
misoprostol group ( study group ) ( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
干预措施: Misoprostol (Drug)
placebo group
( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol.
干预措施: Placebos (Drug)
结局指标
主要结局
blood loss
时间窗: time of operation
reduce intra operative blood loss during myomectomy
次要结局
未报告次要终点
研究者
ahmed nagy shaker ramadan
resident of obstetric and gynecology
Ain Shams Maternity Hospital