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

Phase 4

Completed

• Conditions: Hemorrhage
• Interventions: Drug: Misoprostol + vasopressin; Drug: Vasopressin

• Registration Number: NCT01700478
• Lead Sponsor: University Hospital of the West Indies

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2012-09-25
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Misoprostol + vasopressin, Vasopressin	Misoprostol + vasopressin	Misoprostol 400ug given rectally one hour before surgery.
Misoprostol + vasopressin, Vasopressin	Vasopressin	Misoprostol 400ug given rectally one hour before surgery.

Primary Outcome Measures

Name	Time	Method
Blood loss in millilitres	At the time of surgery

Secondary Outcome Measures

Name	Time	Method
A change in hemoglobin grams per decilitre	At baseline and 24hours after surgery

Trial Locations

Locations (1)

University Hospital of the West Indies; 🇯🇲 Kingston, Jamaica