The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets: Double Blinded Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.
研究概览
简要总结
the study aims to evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing abdominal 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 Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
- Arm 2: intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
- Arm 3: intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets(placebo).
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, Investigator, Outcomes Assessor)
盲法说明
double blinded randomized
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
- •Women aged 16-45 years
- •Appropriate medical status for open surgery (Largest Myoma size from 4 cm up to 20 cm)
- •Baseline hemoglobin ≥9 g/dl
- •No contra-indications to the use of glyopressin or carbitocin
- •Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
- •Not pregnant at the time of presentation
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
intramyometrial Terlipressin injection
intramyometrial Terlipressin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
(After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural Terlipressin will be injected, and then the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
干预措施: Terlipressin (Drug)
intramyometrial Carbetocin injection
intramyometrial Carbetocin injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
(After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural carbitocin will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated)
干预措施: Terlipressin (Drug)
intramyometrial saline injection
intramyometrial saline injection in women undergoing open myomectomy procedure using haemostatic tourniquets.
After the uterus has been reached, the Foley's urethral catheter will be adapted as a uterine tourniquet and will be applied at the base of the uterus before enucleating the fibroid masses. intramural saline as a aplacebo will be injected, and the uterine incision is done and the surgeon can now separate out the fibroids with ease and then amount of blood loss is calculated) and amount of blood loss and operative time is compared between all arms
干预措施: Terlipressin (Drug)
结局指标
主要结局
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets.
时间窗: 12 hours
To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection in decreasing blood loss in women undergoing open myomectomy using haemostatic tourniquets( measuring the amount of blood loss in mm )
次要结局
- 1. To evaluate the efficacy of intramyometrial Terlipressin injection versus intramyometrial Carbetocin injection on hemoglobin level in women undergoing open myomectomy using haemostatic tourniquets.(24 hours)