Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Sponsor

Mt. Hope Maternity Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01581944

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroids	Drug: 2 Doses Goserelin Drug: 3 Doses Goserelin	Phase 3

Detailed Description

Variables noted preoperatively:

Age
Parity
Ethnicity
Ultrasound findings

Variables noted intra-operatively:

Size of largest fibroid
Estimated blood loss

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Other Names: Gonadotropin Releasing Hormone Agonist
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 Other Names: Gonadotropin Releasing Hormone Agonist

Arm

Intervention/Treatment

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

Other Names:

Gonadotropin Releasing Hormone Agonist

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

Other Names:

Gonadotropin Releasing Hormone Agonist

Outcome Measures

Primary Outcome Measures

Intraoperative blood loss [3 months]
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 [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.
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.
Length of operation [Immediately after operation]
The length of operation was calculated from the skin incision to closure (minutes).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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