The Efficacy Of Misoprostol Versus Oxytocin Infusion On Reducing Blood Loss During Abdominal Myomectomy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- intra-operative blood loss
研究概览
简要总结
Uterine leiomyomas, or fibroids, are common benign tumors among women, especially those over 35 years old. They can cause various issues, including heavy menstrual bleeding, anemia, pelvic pain, and pressure symptoms. Surgery is often necessary for symptomatic fibroids, with hysterectomy recommended for women over 40 and myomectomy for those wishing to preserve their uterus. Myomectomy can be performed using different surgical approaches but can be associated with significant morbidity, particularly major blood loss, especially in abdominal myomectomy, where up to 20% of women may require blood transfusion.
Various interventions have been introduced to reduce bleeding during myomectomy, such as tourniquets, bupivacaine plus epinephrine infiltration, vasopressin injection, preoperative GnRH agonist administration, and preoperative ascorbic acid injection. However, these strategies may have complications, be ineffective, expensive, or require extra steps.
Oxytocin, primarily secreted from the pituitary gland, is crucial for uterine contraction during labor and delivery, and is used to prevent postpartum uterine atony and bleeding. However, caution is needed in its use, especially in women with heart disease or hypovolemia.
Misoprostol, a prostaglandin E1 analogue, can reduce bleeding during myomectomy by promoting myometrial contractions and reducing uterine artery blood flow. It can be administered via multiple routes, with rectal administration showing advantages in maintaining high plasma concentrations during surgery. Studies have investigated the effectiveness of single preoperative rectal doses of misoprostol versus preoperative oxytocin in reducing bleeding during abdominal myomectomy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of previous myomectomy
- •Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine.
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Patients who have bleeding disorders.
- •Patients on antiplatelets or anticoagulant before surgery.
- •Anemia (Hb < 10g %).
- •Chronic endocrine or metabolic diseases such as Diabetes.
- •Renal and hepatic impairment.
- •Moderate and morbid Obesity (body mass index > 35 kg/m2).
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
- •Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,
- •history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.
研究组 & 干预措施
misoprostol
receiving a preoperative rectal dose of 800 ug of misoprostol half an hour before surgery
干预措施: Misoprostol 200mcg Tab (Drug)
oxytocin
After the induction of general anaesthesia (GA), an infusion of 40 IU oxytocin in 500 ml normal saline was started at the rate of 250 ml/hour
干预措施: Oxytocin (Drug)
结局指标
主要结局
intra-operative blood loss
时间窗: time of surgery
which was measured at the end of surgery by calculating the sum of blood in the suction bottle and the blood absorbed in the sponges. Dry sponges were weighed before the surgery and the blood-soaked sponges were weighed at the end of the surgery
次要结局
- total surgery time(24 hours)
- blood transfusion(24 hours)
- post-operative Hb(24 hours)
研究者
ahmed nagy shaker ramadan
lecturer
Cairo University