Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.
In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.
In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.
详细描述
Variables noted preoperatively:
- Age
- Parity
- Ethnicity
- Ultrasound findings
Variables noted intra-operatively:
- Size of largest fibroid
- Estimated blood loss
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
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the age of 20 and 45
- •Symptomatic fibroids
- •Presence of regular menstrual cycles
- •Ultrasound confirmation of fibroids
- •Normal cervical smear
排除标准
- •Pregnancy
- •The length of hospital stay was calculated in number of days from the date of the to the date of discharge
- •Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility
研究组 & 干预措施
2 Doses Goserelin
Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.
干预措施: 2 Doses Goserelin (Drug)
3 Doses Goserelin
Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).
干预措施: 3 Doses Goserelin (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: 3 months
Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.
次要结局
- The level of difficulty in enucleation of the fibroid and in achieving hemostasis.(Immediately after the operation)
- Blood transfusion requirement(Intraoperatively and in the postoperative period)
- Length of operation(Immediately after operation)
- Length of hospital stay(Number of days from operation date to discharge date)
研究者
Dr. Bharat Bassaw
Senior Lecturer, Consultant, Head of Obstetrics and Gynaecology
Mt. Hope Maternity Hospital