Back to resultsStudy of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
Primary Purpose
Hemorrhage
Status
Completed
Phase
Phase 4
Locations
Jamaica
Study Type
Interventional
Intervention
Misoprostol + vasopressin
Vasopressin
Sponsored by
About this trial
This is an interventional prevention trial for Hemorrhage focused on measuring Myomectomy
Eligibility Criteria
Inclusion Criteria:
- patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
Exclusion Criteria:
- patients who have had previous myomectomy or previous pelvic surgery.
- patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
- patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
Sites / Locations
- University Hospital of the West Indies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Misoprostol + vasopressin, Vasopressin
Arm Description
Misoprostol 400ug given rectally one hour before surgery.
Outcomes
Primary Outcome Measures
Blood loss in millilitres
Secondary Outcome Measures
A change in hemoglobin grams per decilitre
Full Information
NCT ID
NCT01700478
First Posted
September 25, 2012
Last Updated
February 7, 2013
Sponsor
University Hospital of the West Indies
1. Study Identification
Unique Protocol Identification Number
NCT01700478
Brief Title
Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
Official Title
A Trial Comparing The Use Of Rectal Plus Perivascular Vasopressin With Perivascular Vasopressin Alone To Decrease Bleeding At The Time Of Myomectomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of the West Indies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Myomectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Misoprostol + vasopressin, Vasopressin
Arm Type
Experimental
Arm Description
Misoprostol 400ug given rectally one hour before surgery.
Intervention Type
Drug
Intervention Name(s)
Misoprostol + vasopressin
Other Intervention Name(s)
Cytotec
Intervention Description
400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Other Intervention Name(s)
Anti-diuretic hormone
Intervention Description
Vasopressin was used in all patients during surgery.
Primary Outcome Measure Information:
Title
Blood loss in millilitres
Time Frame
At the time of surgery
Secondary Outcome Measure Information:
Title
A change in hemoglobin grams per decilitre
Time Frame
At baseline and 24hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with symptomatic fibroids who desire future fertility and or who wish to maintain their uterus.
Exclusion Criteria:
patients who have had previous myomectomy or previous pelvic surgery.
patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease.
patients who refuse to participate or give consent to the procedures. Patients with a known allergy to any of the study drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharifa K Frederick, dM
Organizational Affiliation
University Hospital of the West Indies
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of the West Indies
City
Kingston
Country
Jamaica
12. IPD Sharing Statement
Citations:
PubMed Identifier
23876539
Citation
Frederick S, Frederick J, Fletcher H, Reid M, Hardie M, Gardner W. A trial comparing the use of rectal misoprostol plus perivascular vasopressin with perivascular vasopressin alone to decrease myometrial bleeding at the time of abdominal myomectomy. Fertil Steril. 2013 Oct;100(4):1044-9. doi: 10.1016/j.fertnstert.2013.06.022. Epub 2013 Jul 19.
Results Reference
derived
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Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy
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