Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Mt. Hope Maternity Hospital

Status and phase: Completed; Phase 3

Conditions: Fibroids

Treatments: Drug: 3 Doses Goserelin; Drug: 2 Doses Goserelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01581944

MtHopeMaternity0075

Details and patient eligibility

About

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.

Full description

Variables noted preoperatively:

• Age
• Parity
• Ethnicity
• Ultrasound findings

Variables noted intra-operatively:

• Size of largest fibroid
• Estimated blood loss

Enrollment: 68 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 3 patient groups

No Treatment (Control)

No Intervention group

Description:

Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.

2 Doses Goserelin

Experimental group

Description:

Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.

Treatment:

Drug: 2 Doses Goserelin

3 Doses Goserelin

Experimental group

Description:

Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).

Treatment:

Drug: 3 Doses Goserelin