Preoperative Vaginal Dinoprostone Versus Misoprostone in Abdominal Myomectomy

Study Overview
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Brief Summary
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Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy

Detailed Description
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Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy. Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital

Official Title
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Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy

Conditions
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Myoma;Uterus

Intervention / Treatment
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* Drug: Dinoprostone
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30-50 years all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy. Exclusion Criteria: contraindications to dinoprostone or misoprostol, active PID, history of pelvic/ ovarian endometriosis, females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.

Ages Eligible for Study
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Minimum Age: 30 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dinoprostone<br>Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively. | Drug: Dinoprostone<br>* prostaglandin (PG) E2 analog<br>* Other names: Dinoglandin;|
| Experimental: Misoprostol<br>will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively. | Drug: Misoprostol<br>* prostaglandin (PG) E1 analog<br>* Other names: Cytotec;|
| No Intervention: control<br>received a placebo vaginally 2 hrs. preoperatively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze. | all time of the myomectomy operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change hemoglobin levels | Pre and Postoperative hemoglobin levels | within 1 week before operation and 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine leiomyoma, misoprostol, dinoprostone