Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Phase 3

Completed

• Conditions: Fibroids
• Interventions: Drug: 3 Doses Goserelin; Drug: 2 Doses Goserelin

• Registration Number: NCT01581944
• Lead Sponsor: Mt. Hope Maternity Hospital

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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-04
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-04-18
• Last Update Submitted: 2012-04-18
• Study First Posted: 2012-04-20
• Last Update Posted: 2012-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 Doses Goserelin	3 Doses Goserelin	Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).
2 Doses Goserelin	2 Doses Goserelin	Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

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