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

February 7, 2013 updated by: Dr Sharifa Frederick, University Hospital of the West Indies

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston, Jamaica
        • University Hospital of the West Indies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Misoprostol + vasopressin, Vasopressin
Misoprostol 400ug given rectally one hour before surgery.
Drug: Misoprostol + vasopressin
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
Other Names:
  • Cytotec
Drug: Vasopressin
Vasopressin was used in all patients during surgery.
Other Names:
  • Anti-diuretic hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood loss in millilitres
Time Frame: At the time of surgery
At the time of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
A change in hemoglobin grams per decilitre
Time Frame: At baseline and 24hours after surgery
At baseline and 24hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of the West Indies

Investigators

  • Principal Investigator: Sharifa K Frederick, dM, University Hospital of the West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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