Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01581944
Other study ID # MtHopeMaternity0075
Secondary ID
Status Completed
Phase Phase 3
First received April 17, 2012
Last updated April 18, 2012
Start date January 2008
Est. completion date December 2011

Study information

Verified date April 2012
Source Mt. Hope Maternity Hospital
Contact n/a
Is FDA regulated No
Health authority Trinidad and Tobago : Ministry of Health
Study type Interventional

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.


Description:

Variables noted preoperatively:

- Age

- Parity

- Ethnicity

- Ultrasound findings

Variables noted intra-operatively:

- Size of largest fibroid

- Estimated blood loss


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
2 Doses Goserelin
3.6mg administered monthly for 2 months prior to myomectomy
3 Doses Goserelin
3.6mg administered monthly for 3 months prior to myomectomy

Locations

Country Name City State
Trinidad and Tobago Gynaecological Outpatient Clinic; Mt. Hope Maternity Hospital Champs Fleurs

Sponsors (1)

Lead Sponsor Collaborator
Mt. Hope Maternity Hospital

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative blood loss Gonadotropin releasing hormone agonist Goserelin 3.6mg was administered for either 2 or 3 months prior to the operation. 3 months No
Secondary 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 No
Secondary The level of difficulty in enucleation of the fibroid and in achieving hemostasis. 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 No
Secondary Length of operation The length of operation was calculated from the skin incision to closure (minutes). Immediately after operation No
Secondary 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 No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Terminated NCT02209545 - Misoprostol for Reduction of Blood Loss During Fibroid Surgery Phase 4
Completed NCT00332033 - Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids) Phase 2
Recruiting NCT04849858 - Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures Phase 3
Terminated NCT00001850 - Evaluation of Women With Endocrine and Reproductive-Related Conditions
Completed 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
Withdrawn NCT02703246 - Tissue Removal During Hysterectomy: The Effect of Vaginal Versus Abdominal Morcellation on Surgical Outcomes N/A
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
Completed NCT04071574 - Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility Phase 1/Phase 2
Completed NCT02812186 - Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Phase 4
Recruiting NCT02288130 - Ulipristal vs. GnRHa Prior to Laparoscopic Myomectomy Phase 4
Completed NCT04550429 - Uterine Filling Pressure in Hysteroscopy N/A
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