Impact of Misoprostol on Blood Loss In Myomectomy Operations

Study Overview
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Brief Summary
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The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications

Detailed Description
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This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital. A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial. The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Official Title
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Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations

Conditions
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Leiomyoma

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo( for misoprostol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal patients aged between 35 to 50 years old. Five or less symptomatic uterine myomas . Maximum diameter of the largest myoma is 6 cm . All myomas are subserous or intramural. Uterine size less than 24 weeks pregnancy Exclusion Criteria: History of previous surgery. Allergy to Misoprostol. Hypertension. Cardiac and Pulmonary diseases. Patients who have bleeding disorders. Anemia (Hb < 10g %). Chronic endocrine or metabolic diseases such as Diabetes. Obesity (body mass index > 30 kg/m2). Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myomectomy, rectal Misoprostol<br>25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation. | Drug: Misoprostol<br>* 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation<br>* Other names: Cytotec;|
| Active Comparator: Myomectomy, Placebo<br>Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation. | Drug: Placebo( for misoprostol)<br>* Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss |  | time from peritoneum opening till its closure around (1 Hour) |