Impact of Misoprostol on Blood Loss In Myomectomy Operations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-07-31

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

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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.

Conditions

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Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Myomectomy, rectal Misoprostol

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation

Myomectomy, Placebo

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Group Type ACTIVE_COMPARATOR

Placebo( for misoprostol)

Intervention Type DRUG

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Interventions

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Misoprostol

25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation

Intervention Type DRUG

Placebo( for misoprostol)

Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Intervention Type DRUG

Other Intervention Names

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Cytotec

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No