Fibroids
Conditions
Keywords
myomectomy, GnRH, blood loss
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
Interventions
DRUG3 Doses Goserelin
3.6mg administered monthly for 3 months prior to myomectomy
DRUG2 Doses Goserelin
3.6mg administered monthly for 2 months prior to myomectomy
Sponsors
Mt. Hope Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | 3 months | Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion requirement | 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. |
| The level of difficulty in enucleation of the fibroid and in achieving hemostasis. | 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. |
| Length of operation | Immediately after operation | The length of operation was calculated from the skin incision to closure (minutes). |
| Length of hospital stay | 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. |
Countries
Trinidad and Tobago
Outcome results
None listed