A Phase 3 interventional study of Misoprostol in Blood Loss, Surgical and Uterine Myoma, sponsored by Pak Emirates Military Hospital. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Pak Emirates Military Hospital · Phase 3, Interventional, and Other
A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups.
100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.
After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity \& BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.
The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 200 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Pak Emirates Military Hospital is the lead sponsor of 22 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.
Drug: Misoprostol
In control group no dose will be administered
400ug misoprostol will be administered through rectal route, 1 hour before surgery to assess its effect on intra-operative blood loss during myomectomy
Also known as: Prosotec
Intraoperative blood loss
Intraoperative blood loss will be recorded by a trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.
Time frame: During the surgical procedure
Plan to share: No — Overall results will be shared only.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Pak Emirates Military Hospital