Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Fibroids
• Intervention / Treatment: Drug: 2 Doses Goserelin; Drug: 3 Doses Goserelin

Detailed Description

Variables noted preoperatively:

• Age
• Parity
• Ethnicity
• Ultrasound findings

Variables noted intra-operatively:

• Size of largest fibroid
• Estimated blood loss

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Trinidad and Tobago
  • Champs Fleurs, Trinidad and Tobago, 00000
    • Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mt. Hope Maternity Hospital
• Investigators: Principal Investigator: Dr Bharat Bassaw, MBBS FRCOG, Mt. Hope Maternity Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): April 20, 2012
• Last Update Submitted That Met QC Criteria: April 18, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: blood loss; GnRH; myomectomy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Goserelin; Hormones
• Other Study ID Numbers: MtHopeMaternity0075