Completed

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

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What is being tested

Misoprostol + vasopressin

+ Vasopressin

Drug
Who is being recruted

Hemorrhage

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 25 to 40 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 4
Interventional
Study Start: February 2005
See protocol details

Summary

Principal SponsorUniversity Hospital of the West Indies
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2005

Actual date on which the first participant was enrolled.

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.

Official TitleA Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
NCT01700478
Principal SponsorUniversity Hospital of the West Indies
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 25 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

1 inclusion criteria required to participate
patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Misoprostol 400ug given rectally one hour before surgery.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospital of the West Indies

Kingston, JamaicaOpen University Hospital of the West Indies in Google Maps
CompletedOne Study Center