Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Bharat Bassaw, Mt. Hope Maternity Hospital
ClinicalTrials.gov Identifier:
NCT01581944
First received: April 17, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Fibroids
Drug: 2 Doses Goserelin
Drug: 3 Doses Goserelin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.

Resource links provided by NLM:


Further study details as provided by Mt. Hope Maternity Hospital:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation.


Secondary Outcome Measures:
  • Blood transfusion requirement [ Time Frame: Intraoperatively and in the postoperative period ] [ Designated as safety issue: No ]
    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.

  • The level of difficulty in enucleation of the fibroid and in achieving hemostasis. [ Time Frame: Immediately after the operation ] [ Designated as safety issue: No ]
    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.

  • Length of operation [ Time Frame: Immediately after operation ] [ Designated as safety issue: No ]
    The length of operation was calculated from the skin incision to closure (minutes).

  • Length of hospital stay [ Time Frame: Number of days from operation date to discharge date ] [ Designated as safety issue: No ]
    The length of hospital stay was calculated in number of days from the date of the to the date of discharge.


Enrollment: 68
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Treatment (Control)
Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.
Experimental: 2 Doses Goserelin
Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.
Drug: 2 Doses Goserelin
3.6mg administered monthly for 2 months prior to myomectomy
Other Name: Gonadotropin Releasing Hormone Agonist
Experimental: 3 Doses Goserelin
Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).
Drug: 3 Doses Goserelin
3.6mg administered monthly for 3 months prior to myomectomy
Other Name: Gonadotropin Releasing Hormone Agonist

Detailed Description:

Variables noted preoperatively:

  • Age
  • Parity
  • Ethnicity
  • Ultrasound findings

Variables noted intra-operatively:

  • Size of largest fibroid
  • Estimated blood loss
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581944

Locations
Trinidad and Tobago
Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital
Champs Fleurs, Trinidad and Tobago, 00000
Sponsors and Collaborators
Mt. Hope Maternity Hospital
Investigators
Principal Investigator: Dr Bharat Bassaw, MBBS FRCOG Mt. Hope Maternity Hospital
  More Information

No publications provided

Responsible Party: Dr. Bharat Bassaw, Senior Lecturer, Consultant, Head of Obstetrics and Gynaecology, Mt. Hope Maternity Hospital
ClinicalTrials.gov Identifier: NCT01581944     History of Changes
Other Study ID Numbers: MtHopeMaternity0075
Study First Received: April 17, 2012
Last Updated: April 18, 2012
Health Authority: Trinidad and Tobago : Ministry of Health

Keywords provided by Mt. Hope Maternity Hospital:
myomectomy
GnRH
blood loss

Additional relevant MeSH terms:
Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Hormones
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014