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Clinical Trial 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.


Clinical Trial Description

Variables noted preoperatively:

- Age

- Parity

- Ethnicity

- Ultrasound findings

Variables noted intra-operatively:

- Size of largest fibroid

- Estimated blood loss ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01581944
Study type Interventional
Source Mt. Hope Maternity Hospital
Contact
Status Completed
Phase Phase 3
Start date January 2008
Completion date December 2011

See also
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Completed NCT00332033 - Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids) Phase 2
Active, not recruiting NCT02620748 - Use of Intravenous Tranexamic Acid During Myomectomy Phase 1
Completed NCT02954744 - High-intensity Focused Ultrasound in Treatment of Uterine Fibroid N/A
Terminated NCT00710346 - Establishment of Fibroid Tissue Bank
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Not yet recruiting NCT01347385 - Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy N/A
Completed NCT02620345 - Fibroids in Women of Reproductive Age and Women Pregnancy Phase 4
Enrolling by invitation NCT02812186 - Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Phase 4
Recruiting NCT02288130 - Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy Phase 4
Withdrawn NCT01671215 - Endometrial and Myometrial Changes, With and Without Fibroids N/A
Completed NCT01936493 - Biologic Predictors of Leiomyoma Treatment Outcomes N/A
Completed NCT00995878 - The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids. Phase 4