The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations: Double Blinded Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy
研究概览
简要总结
Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
详细描述
This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure
- Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure
- Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previous myomectomy
- •History of bleeding disorders
- •Concurrent anticoagulation therapy
- •History of Uncontrolled ischaemic heart disease
- •Any pelvic abnormalities requiring concomitant surgery
- •Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
- •Inability to understand and provide written informed consent
研究组 & 干预措施
intracapsular myomectomy Terlipressin injection
intracapsular myomectomy Terlipressin injection in women undergoing laparoscopic myomectomy procedure
干预措施: Terlipressin (Drug)
intracapsular myomectomy Carbetocin injection
intracapsular myomectomy Carbetocin injection in women undergoing laparoscopic myomectomy procedure
干预措施: Terlipressin (Drug)
intramyometrial saline
intracapsular myomectomy saline injection in women undergoing laparoscopic myomectomy procedure
干预措施: Terlipressin (Drug)
结局指标
主要结局
intracapsular injection of Terlipressin versus Carbetocin on change blood loss in patient in laparoscopic myomectomy
时间窗: 12 hours
measure the amount of blood loss in mm after intracapsular injection of Terlipressin versus Carbetocin versus saline as aplacebo in women undergoing laparoscopic myomectomy
次要结局
- 1. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on hemoglobin(24 hours)
- 2. To evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin on operative time(12 hours)