Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

NCT ID: NCT01581944

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-12-31

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

Conditions

Fibroids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No Treatment (Control)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

2 Doses Goserelin

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

Group Type: EXPERIMENTAL

2 Doses Goserelin

Intervention Type: DRUG

3.6mg administered monthly for 2 months prior to myomectomy

3 Doses Goserelin

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

Group Type: EXPERIMENTAL

3 Doses Goserelin

Intervention Type: DRUG

3.6mg administered monthly for 3 months prior to myomectomy

Interventions

2 Doses Goserelin

3.6mg administered monthly for 2 months prior to myomectomy

Intervention Type: DRUG

3 Doses Goserelin

3.6mg administered monthly for 3 months prior to myomectomy

Intervention Type: DRUG

Other Intervention Names

Gonadotropin Releasing Hormone Agonist; Gonadotropin Releasing Hormone Agonist

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mt. Hope Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Bharat Bassaw

Senior Lecturer, Consultant, Head of Obstetrics and Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Bharat Bassaw, MBBS FRCOG

Role: PRINCIPAL_INVESTIGATOR

Mt. Hope Maternity Hospital

Locations

Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital

Champs Fleurs, , Trinidad and Tobago

Countries

Trinidad and Tobago

Other Identifiers

MtHopeMaternity0075

Identifier Type: -

Identifier Source: org_study_id