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Completed

NCT Number: NCT01581944

Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

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.

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Key information

Conditions

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

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital

Champs Fleurs, 00000, Trinidad and Tobago

About this study

Variables noted preoperatively:

  • Age
  • Parity
  • Ethnicity
  • Ultrasound findings

Variables noted intra-operatively:

  • Size of largest fibroid
  • Estimated blood loss

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 Doses Goserelin

Drug

3.6mg administered monthly for 2 months prior to myomectomy

Other names: Gonadotropin Releasing Hormone Agonist

3 Doses Goserelin

Drug

3.6mg administered monthly for 3 months prior to myomectomy

Other names: Gonadotropin Releasing Hormone Agonist

Primary outcomes

  1. Intraoperative blood loss

    Time frame: 3 months

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

Secondary outcomes

  1. Blood transfusion requirement

    Time frame: Intraoperatively and in the postoperative period

    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.

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

    Time frame: Immediately after the operation

    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.

  3. Length of operation

    Time frame: Immediately after operation

    The length of operation was calculated from the skin incision to closure (minutes).

  4. Length of hospital stay

    Time frame: Number of days from operation date to discharge date

    The length of hospital stay was calculated in number of days from the date of the to the date of discharge.

Sponsors and collaborators

Lead sponsor

Mt. Hope Maternity Hospital

Other

Registry information

Official study title

Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 20, 2012
Registry last updated
Apr 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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