Rectal Misoprostol and Blood Loss During Abdominal Hysterectomy

Study Overview
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Brief Summary
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Hysterectomy, as any major operation, can cause complications, as hemorrhage which may occur in some cases and sometimes requiring blood transfusion. Recent study proved that misoprostol success in reducing blood loss during total abdominal hysterectomy when used once before the surgery.

Detailed Description
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In this study we tried to assess the efficacy of misoprostol in minimize blood loss during hysterectomy when used as single preoperative dose via rectal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

Official Title
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Evaluation of the Effect of Rectal Misoprostol on Blood Loss During Abdominal Hysterectomy: A Double Blind Randomized Controlled Trial.

Conditions
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Blood Loss

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A- Age: adult female >18 years old. B- Any women undergoing abdominal hysterectomy. C- No contraindications to misoprostol. Exclusion Criteria: A -Women with any contraindications to misoprostol including heart disease, mitral stenosis , severe hypertension ( diastolic pressure over100mm Hg) , hematologic disorders (as sickle cell anemia ), glaucoma, bronchial asthma, liver disease. B- Known history of or active medical disorder as DM . C- Pelvic endometriosis and adnexal mass. D- Those who had undergone previous myomectomy. E- Women who received GnRH analogues and mifepristone and who are allergic to prostaglandins. F- Women with mental impairment or incompetent in giving consent. G- Women who don't wish to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Misoprostol<br>60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally | Drug: Misoprostol<br>* 60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally<br>* Other names: prostaglandin E1 analogue;|
| Placebo Comparator: Placebo<br>60 minutes before the surgery 2 tablets of placebo tablets inserted rectally | Drug: Placebo<br>* 60 minutes before the surgery 2 tablet of placebo inserted rectally<br>* Other names: Dizirest B6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | amount of intra-operative blood loss | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hemoglobin level | level of serum hemoglobin postoperatively | 8 months | 

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