Impact of Misoprostol on Blood Loss In Myomectomy Operations

Leiomyoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061657
• Other study ID #: AIN-1111-MM
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2014
• Last updated: August 9, 2014
• Start date: June 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
• Placebo( for misoprostol)
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Locations

Country	Name	City	State
Egypt	Ain Shams University, Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative blood loss		time from peritoneum opening till its closure around (1 Hour)	No