Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Study Overview
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Brief Summary
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Purpose is to identify if misoprostol in addition to local vasopressin decreases blood loss when compared to vasopressin alone, which is our current practice at this time. The study will be double-blinded with neither the patient nor the researcher knowing whether the placebo or the misoprostol was given. We will monitor patients for decrease in hemoglobin and hematocrit, need for transfusion, and operative time among other measures of perioperative morbidity to see if the addition of misoprostol makes a significant difference. We will also observe patients to see if there are any side effects of misoprostol that make its use undesirable.

Detailed Description
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All women with planned myomectomy receive Depo Leupron prior to surgery per standard care and undergo routine pre-operative laboratory testing including hemoglobin and hematocrit. If enrolled in the study, patients will be consented at their pre-op appointment for the study and be asked to complete a visual analog scale to assess pre-operative pain. Patients will be randomized to receive misoprostol 800mcg per rectum or an identical inert tablet(s) per rectum 30 minutes preoperatively. Randomization will be performed by a third party so that neither the surgeon nor patient will know which intervention was performed, and interventions will be placed in sealed, sequentially numbered, opaque envelopes. Researcher team will have all needed data corresponding with randomized code which will be broken at conclusion of study and will be able to match code with patient's initials and medical record number after study completion to analyze data. Myomectomy will then be performed per standard care with the use of local vasopressin to aid in decreasing blood loss per our normal standard of care.

Official Title
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Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy

Conditions
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Myomectomy; Surgical Blood Loss

Intervention / Treatment
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* Drug: Misoprostol 100Mcg Tab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age 20-50 y/o who plan to undergo abdominal myomectomy for symptomatic myomatous uterus Exclusion Criteria: Patient with contraindication to misoprostol or vasopressin, personal history or cardiac or pulmonary disease, history of prior myomectomy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective double-blinded study completed at a tertiary care center
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol 100Mcg Tab<br>Patients will receive misoprostol 400mcg per rectum 30 minutes preoperatively. | Drug: Misoprostol 100Mcg Tab<br> <br> * Other names: Cytotec;|
| Placebo Comparator: Placebo<br>Patients will receive identical inert tablets per rectum 30 minutes preoperatively. | Drug: Placebo<br> <br> * Other names: Placebo tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical blood loss | Estimated blood loss during surgery | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile morbiditiy | Evidence of fever or infection postoperatively | 24 hours postop | 
| Need for blood transfusion | Patient requirement of blood transfusion | intraoperative to 24 hours postoperative | 
| Pain score | Assessment of patient subjective pain score | 24 hours postop | 
| Medication side-effects | Surveillance for any adverse side effects from misoprostol | 24 hours postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myomectomy, Misoprostol, Vasopressin, Blood loss