Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

NCT01581944 | Completed Phase 3 DMC

• 1 other identifier: MtHopeMaternity0075
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroids

Keywords

myomectomy; GnRH; blood loss

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.

  3 months

Secondary Outcomes (4)

• Blood transfusion requirement

  Intraoperatively and in the postoperative period

• The level of difficulty in enucleation of the fibroid and in achieving hemostasis.

  Immediately after the operation

• Length of operation

  Immediately after operation

• Length of hospital stay

  Number of days from operation date to discharge date

Study Arms (3)

No Treatment (Control)

NO INTERVENTION

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

2 Doses Goserelin

EXPERIMENTAL

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

Drug: 2 Doses Goserelin

3 Doses Goserelin

EXPERIMENTAL

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

Drug: 3 Doses Goserelin

Interventions

2 Doses Goserelin DRUG

3.6mg administered monthly for 2 months prior to myomectomy

Also known as: Gonadotropin Releasing Hormone Agonist

2 Doses Goserelin

3 Doses Goserelin DRUG

3.6mg administered monthly for 3 months prior to myomectomy

Also known as: Gonadotropin Releasing Hormone Agonist

3 Doses Goserelin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the age of 20 and 45
• Symptomatic fibroids
• Presence of regular menstrual cycles
• Ultrasound confirmation of fibroids
• Normal cervical smear

You may not qualify if:

• 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

Sponsors & Collaborators

• Mt. Hope Maternity Hospital: lead

Study Sites (1)

Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital

Champs Fleurs, 00000, Trinidad and Tobago

Location

MeSH Terms

Conditions

Leiomyoma; Hemorrhage

Interventions

Goserelin; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Dr Bharat Bassaw, MBBS FRCOG

  Mt. Hope Maternity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Consultant, Head of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 20, 2012
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

TR (1)