Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581944
• Other study ID #: MtHopeMaternity0075
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2012
• Last updated: April 18, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Mt. Hope Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Trinidad and Tobago : Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Variables noted preoperatively:

• Age

• Parity

• Ethnicity

• Ultrasound findings

Variables noted intra-operatively:

• Size of largest fibroid

• Estimated blood loss

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibroids

Intervention

Drug:
• 2 Doses Goserelin
3.6mg administered monthly for 2 months prior to myomectomy
• 3 Doses Goserelin
3.6mg administered monthly for 3 months prior to myomectomy

Locations

Country	Name	City	State
Trinidad and Tobago	Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital	Champs Fleurs

Sponsors (1)

Lead Sponsor	Collaborator
Mt. Hope Maternity Hospital

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.	3 months	No
Secondary	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	No
Secondary	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	No
Secondary	Length of operation	The length of operation was calculated from the skin incision to closure (minutes).	Immediately after operation	No
Secondary	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	No