Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
This study was done to determine if the use of a combination of preoperative rectal misoprostol 400µg used with intraoperative perivascular vasopressin is better than perivascular vasopressin used alone to decrease bleeding at myomectomy.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy|
- Blood loss in millilitres [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
- A change in hemoglobin grams per decilitre [ Time Frame: At baseline and 24hours after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Experimental: Misoprostol + vasopressin, Vasopressin
Misoprostol 400ug given rectally one hour before surgery.
Drug: Misoprostol + vasopressin
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
Other Name: CytotecDrug: Vasopressin
Vasopressin was used in all patients during surgery.
Other Name: Anti-diuretic hormone
A myomectomy is a fertility sparing procedure in which fibroids are removed from the uterus. This procedure can be associated with significant blood loss which can result in significant morbidity and mortality. The drug misoprostol which has been been use in the treatment of postpartum hemorrhage was given to subset of patients who were scheduled to undergo elective myomectomy at the University hospital of the West Indies and from the private practice of the participating doctors who were invited to participate in the study. Patients were randomized to receive or not to receive pre-operative rectal misoprostol 400µg, 60 minutes before surgery. Twenty five patients received misoprostol and twenty patients did not.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700478
|University Hospital of the West Indies|
|Principal Investigator:||Sharifa K Frederick, dM||University Hospital of the West Indies|