Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

只有注册用户可以翻译文章

登陆注册

链接已保存到剪贴板

状态已完成

赞助商

Mt. Hope Maternity Hospital

临床试验: NCT01581944

BioSeek: NCT01581944

关键词

抽象

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.

描述

Variables noted preoperatively:

- Age

- Parity

- Ethnicity

- Ultrasound findings

Variables noted intra-operatively:

- Size of largest fibroid

- Estimated blood loss

日期

最后验证:	03/31/2012
首次提交:	04/16/2012
提交的预估入学人数:	04/17/2012
首次发布:	04/19/2012
上次提交的更新:	04/17/2012
最近更新发布:	04/19/2012
实际学习开始日期:	12/31/2007
预计主要完成日期:	11/30/2011
预计完成日期:	11/30/2011

状况或疾病

Fibroids

干预/治疗

Drug: 2 Doses Goserelin

Drug: 3 Doses Goserelin

相

相 3

手臂组

臂	干预/治疗
No Intervention: No Treatment (Control) Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.
Experimental: 2 Doses Goserelin Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.	Drug: 2 Doses Goserelin 3.6mg administered monthly for 2 months prior to myomectomy
Experimental: 3 Doses Goserelin Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).	Drug: 3 Doses Goserelin 3.6mg administered monthly for 3 months prior to myomectomy

资格标准

有资格学习的年龄	20 Years 至 20 Years
有资格学习的性别	Female
接受健康志愿者	是
标准	Inclusion Criteria: - Women between the age of 20 and 45 - Symptomatic fibroids - Presence of regular menstrual cycles - Ultrasound confirmation of fibroids - Normal cervical smear Exclusion Criteria: - 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

结果

主要结果指标

1. Intraoperative blood loss [3 months]

Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.

次要成果指标

1. Blood transfusion requirement [Intraoperatively and in the postoperative period]

The hemoglobin level of each woman was measured on day 1 post operative and a blood transfusion was recommended if the hemoglobin level was <9g/dl.

2. The level of difficulty in enucleation of the fibroid and in achieving hemostasis. [Immediately after the operation]

The surgeons were asked to record the level of difficulty in enucleation (shelling out) of the fibroids and in securing hemostasis. They were asked to state if it was Easy, moderate or difficult.

3. Length of operation [Immediately after operation]

The length of operation was calculated from the skin incision to closure (minutes).

4. Length of hospital stay [Number of days from operation date to discharge date]

The length of hospital stay was calculated in number of days from the date of the to the date of discharge.

Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

关键词

fibroma

leiomyoma

hemorrhage

menorrhagia

抽象

描述

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

科学支持的最完整的草药数据库