Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
Primary Purpose
Fibroids
Status
Completed
Phase
Phase 3
Locations
Trinidad and Tobago
Study Type
Interventional
Intervention
2 Doses Goserelin
3 Doses Goserelin
Sponsored by
About this trial
This is an interventional treatment trial for Fibroids focused on measuring myomectomy, GnRH, blood loss
Eligibility Criteria
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
Sites / Locations
- Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
No Treatment (Control)
2 Doses Goserelin
3 Doses Goserelin
Arm Description
Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.
Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.
Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).
Outcomes
Primary Outcome Measures
Intraoperative blood loss
Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.
Secondary Outcome Measures
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.
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.
Length of operation
The length of operation was calculated from the skin incision to closure (minutes).
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.
Full Information
NCT ID
NCT01581944
First Posted
April 17, 2012
Last Updated
April 18, 2012
Sponsor
Mt. Hope Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01581944
Brief Title
Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
Official Title
Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mt. Hope Maternity Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Variables noted preoperatively:
Age
Parity
Ethnicity
Ultrasound findings
Variables noted intra-operatively:
Size of largest fibroid
Estimated blood loss
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibroids
Keywords
myomectomy, GnRH, blood loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Treatment (Control)
Arm Type
No Intervention
Arm Description
Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.
Arm Title
2 Doses Goserelin
Arm Type
Experimental
Arm Description
Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.
Arm Title
3 Doses Goserelin
Arm Type
Experimental
Arm Description
Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).
Intervention Type
Drug
Intervention Name(s)
2 Doses Goserelin
Other Intervention Name(s)
Gonadotropin Releasing Hormone Agonist
Intervention Description
3.6mg administered monthly for 2 months prior to myomectomy
Intervention Type
Drug
Intervention Name(s)
3 Doses Goserelin
Other Intervention Name(s)
Gonadotropin Releasing Hormone Agonist
Intervention Description
3.6mg administered monthly for 3 months prior to myomectomy
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Blood transfusion requirement
Description
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.
Time Frame
Intraoperatively and in the postoperative period
Title
The level of difficulty in enucleation of the fibroid and in achieving hemostasis.
Description
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.
Time Frame
Immediately after the operation
Title
Length of operation
Description
The length of operation was calculated from the skin incision to closure (minutes).
Time Frame
Immediately after operation
Title
Length of hospital stay
Description
The length of hospital stay was calculated in number of days from the date of the to the date of discharge.
Time Frame
Number of days from operation date to discharge date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Bharat Bassaw, MBBS FRCOG
Organizational Affiliation
Mt. Hope Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital
City
Champs Fleurs
ZIP/Postal Code
00000
Country
Trinidad and Tobago
12. IPD Sharing Statement
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Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
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