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Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

NCT01581944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-04-20

No results posted yet for this study

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.

Conditions

  • Fibroids

Interventions

DRUG

2 Doses Goserelin

3.6mg administered monthly for 2 months prior to myomectomy

DRUG

3 Doses Goserelin

3.6mg administered monthly for 3 months prior to myomectomy

Sponsors & Collaborators

  • Mt. Hope Maternity Hospital

    lead OTHER

Principal Investigators

  • Dr Bharat Bassaw, MBBS FRCOG · Mt. Hope Maternity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Trinidad and Tobago

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01581944 on ClinicalTrials.gov