Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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Variables noted preoperatively: Age Parity Ethnicity Ultrasound findings Variables noted intra-operatively: Size of largest fibroid Estimated blood loss

Official Title
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Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.

Conditions
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Fibroids

Intervention / Treatment
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* Drug: 2 Doses Goserelin
* Drug: 3 Doses Goserelin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Treatment (Control)<br>Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy. | |
| Experimental: 2 Doses Goserelin<br>Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy. | Drug: 2 Doses Goserelin<br>* 3.6mg administered monthly for 2 months prior to myomectomy<br>* Other names: Gonadotropin Releasing Hormone Agonist;|
| Experimental: 3 Doses Goserelin<br>Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections). | Drug: 3 Doses Goserelin<br>* 3.6mg administered monthly for 3 months prior to myomectomy<br>* Other names: Gonadotropin Releasing Hormone Agonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood transfusion requirement | 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. | Intraoperatively and in the postoperative period | 
| The level of difficulty in enucleation of the fibroid and in achieving hemostasis. | 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. | Immediately after the operation | 
| Length of operation | The length of operation was calculated from the skin incision to closure (minutes). | Immediately after operation | 
| Length of hospital stay | The length of hospital stay was calculated in number of days from the date of the to the date of discharge. | Number of days from operation date to discharge date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myomectomy, GnRH, blood loss