A Phase 3 interventional study of Misoprostol and Placebo( for misoprostol) in Leiomyoma, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-08-12.
Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention
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
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 50 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
Drug: Misoprostol
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Drug: Placebo( for misoprostol)
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
Also known as: Cytotec
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
intraoperative blood loss
Time frame: time from peritoneum opening till its closure around (1 Hour)
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Ain Shams University