The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
研究概览
简要总结
For gynecologists, reaching a conclusion about the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level and decreasing blood loss in women undergoing open myomectomy that would influence the clinical decision and best practice. Besides enriching the clinical evidence in open myomectomy without using haemostatic tourniquets. For society, our conclusion and recommendation shall maximize the benefits and managing the benefits of the technique used. Moreover, providing more information for women undergoing open myomectomy without using haemostatic tourniquets.
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 Terlipressin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure without using haemostatic tourniquets
- Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure without using haemostatic tourniquets 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 computergenerated 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)
盲法说明
Double Blinded Randomized Placebo-Controlled Trial
入排标准
- 年龄范围
- 16 Years 至 40 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
- 未提供
研究组 & 干预措施
intramyometrial Terlipressin injection in women undergoing open myomectomy
intramyometrial Terlipressin injection
干预措施: Terlipressin (Drug)
intramyometrial Carbetocin injection in women undergoing open myomectomy
intramyometrial Carbetocin injection
干预措施: Carbetocin (Drug)
intramyometrial saline injection in women undergoing open myomectomy procedure
intramyometrial saline injection in women
干预措施: Saline (Drug)
结局指标
主要结局
To measure the volume of intraoperative blood loss in each group without using haemostatic tourniquets
时间窗: 12 hours
the volume of intraoperative blood loss in ml myomectomy without using haemostatic tourniquets
次要结局
- To measure the pre and postoperative hemoglobin level without using haemostatic tourniquets(24 hours)
- To measure the operative time in each group without using haemostatic tourniquets(24 hours)
- to assess the measure the severity of pain using VAS score(24 hours)