A Randomized Controlled Trial of the Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 900
- 主要终点
- Haemoglobin Change
研究概览
简要总结
The uterine fibroids are the most common benign tumors found in the female reproductive system. Uterine fibroids commonly cause heavy menstrual periods. The prevalence of uterine fibroids is significantly affecting up to 70-80% of women by the age of 50, with an inconsistent impact on women of African origin. Carbitocin is a synthetic analogue of oxytocin which has a longer half-life than oxytocin. A Cochrane review and meta-analysis studies found that carbitocin reduced the use of additional uterotonics and transfusion. However, few of these studies was done during myomectomy.
详细描述
INTRODUCTION The uterine fibroids - heavy bleeding during myomectomy.
The prevalence - 70-80% of women by the age of 50.
Common in black women.
Cabetocin is a synthetic analogue of oxytocin, with a longer half-life than oxytocin.
A Cochrane review and meta-analysis noted that cabetocin reduced the use of additional uterotonics and blood transfusion, with only few during myomectomy and results inconsistent
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Both the participants, investigator and the assessor of the outcomes will be masked.
only the anesthetic that will be administering the drugs or placebo will know the drug
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All consented women booked for myomectomy.
- •No know allergy to Cabetocin.
- •Billed for open abdominal myomectomy.
排除标准
- •Declined consent
- •Allergy to Cabetocin
- •Planned for additional uterotonic
- •Prior history of thromboembolism,
- •With bleeding disorders
- •History of renal disease
- •History of liver pathology
- •Chronic anaemia
- •Billed for vaginal or laparoscopic myomectomy
- •Patients received preoperative embolization or Gn-Rh analogue.
- •Type 8: Non-myometrial or ectopic
结局指标
主要结局
Haemoglobin Change
时间窗: 24months
Pre and Post operative Haemoglobin will be compared
次要结局
- Transfusion rates(24months)
研究者
Darlington-Peter Chibuzor Ugoji
Dr.
Alex Ekwueme Federal University Teaching Hospital