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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.
Variables noted preoperatively:
Variables noted intra-operatively:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 3 Doses Goserelin | Experimental | Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 Doses Goserelin | Drug | 3.6mg administered monthly for 2 months prior to myomectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood transfusion requirement | 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. | Intraoperatively and in the postoperative period |
| The level of difficulty in enucleation of the fibroid and in achieving hemostasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Bharat Bassaw, MBBS FRCOG | Mt. Hope Maternity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital | Champs Fleurs | 00000 | Trinidad and Tobago |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| 3 Doses Goserelin | Drug | 3.6mg administered monthly for 3 months prior to myomectomy |
|
|
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. |
| Immediately after the operation |
| Length of operation | The length of operation was calculated from the skin incision to closure (minutes). | Immediately after operation |
| Length of hospital stay | The length of hospital stay was calculated in number of days from the date of the to the date of discharge. | Number of days from operation date to discharge date |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |