Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy

Hemorrhage Clinical Trial

Official title:

A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700478
• Other study ID #: MV-001
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2012
• Last updated: February 7, 2013
• Start date: February 2005
• Est. completion date: April 2005

Study information

• Verified date: October 2012
• Source: University Hospital of the West Indies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.

Description:

A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.

Exclusion Criteria:

• patients who have had previous myomectomy or previous pelvic surgery.

• patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.

• patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• Misoprostol + vasopressin
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
• Vasopressin
Vasopressin was used in all patients during surgery.

Locations

Country	Name	City	State
Jamaica	University Hospital of the West Indies	Kingston

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of the West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss in millilitres		At the time of surgery	No
Secondary	A change in hemoglobin grams per decilitre		At baseline and 24hours after surgery	No