NCT04080323已完成3 期
Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- decrease blood loss during hysterectomy
研究概览
简要总结
In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Patients presenting for hysterectomy for any benign indication including uterine fibroids.
- •Age ≥ 18 years
- •Pre-operative hemoglobin >8 g/dl
- •Willing to have dinoprostone or a placebo prior to hysterectomy
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •• Patients with known or suspected endometrial/ovarian/cervical cancer.
- •Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
- •Patients currently undergoing treatment for any type of cancer.
- •Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism)
- •History of allergic reactions to dinoprostone.
研究组 & 干预措施
dinoprostone 3 mg
Experimental
60 minutes before the surgery 3 mg of dinoprostone inserted vaginally
干预措施: Dinoprostone 3 mg (Drug)
placebo
Placebo Comparator
60 minutes before the surgery 1 tablet of placebo inserted vaginally
干预措施: placebo (Drug)
结局指标
主要结局
decrease blood loss during hysterectomy
时间窗: intraoperative
decrease blood loss during hysterectomy in ml
次要结局
- postoperative hemoglobin level(24 hours)
研究者
Ahmed Samy aly ashour
assistant professor
Cairo University
研究点 (1)
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