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.

Status Completed

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.

Clinical Trial Description

Variables noted preoperatively:

• Age

• Parity

• Ethnicity

• Ultrasound findings

Variables noted intra-operatively:

• Size of largest fibroid

• Estimated blood loss ;

Study Design

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

Related Conditions & MeSH terms

• Fibroids

• NCT number: NCT01581944
• Study type: Interventional
• Source: Mt. Hope Maternity Hospital
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Completion date: December 2011