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

Study Overview
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Brief Summary
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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
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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 Title
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A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy

Conditions
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Hemorrhage

Intervention / Treatment
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* Drug: Misoprostol + vasopressin
* Drug: Vasopressin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss in millilitres |  | At the time of surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myomectomy