NCT02061657

Impact of Misoprostol on Blood Loss In Myomectomy Operations

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 35 Years – 50 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Leiomyoma

Interventions

Type	Name	Description
DRUG	Misoprostol	25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
DRUG	Placebo( for misoprostol)	Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2014-02-13
• Last updated: 2014-08-12

Locations

1 site across 1 country: Egypt