Impact of Misoprostol on Blood Loss In Myomectomy Operations

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Leiomyoma

Treatments: Drug: Misoprostol; Drug: Placebo( for misoprostol)

Study type: Interventional

Funder types: Other

Identifiers

NCT02061657

AIN-1111-MM

Details and patient eligibility

About

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

Full description

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.

Enrollment: 50 patients

Sex: Female

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Myomectomy, rectal Misoprostol

Experimental group

Description:

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

Treatment:

Drug: Misoprostol

Myomectomy, Placebo

Active Comparator group

Description:

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

Treatment:

Drug: Placebo( for misoprostol)