Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Primary Purpose
Blood Loss During Vaginal Hysterectomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vasopressin
Sponsored by

About this trial
This is an interventional treatment trial for Blood Loss During Vaginal Hysterectomy
Eligibility Criteria
Inclusion Criteria:
- women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures
Exclusion Criteria:
- women with a significant medical condition, including severe liver disease, congestive heart failure, documented coronary artery disease, impaired renal function determined by an elevated serum creatinine, asthma with steroid use in the past year, and migraines
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No injection
Injection of vasopressin
Arm Description
Patients did not receive an injection at cervix prior to beginning the procedure
Patients will be randomized to receive 20cc of dilute vasopressin (20units in 50cc normal saline)injected at cervix at beginning of the hysterectomy
Outcomes
Primary Outcome Measures
Intra-operative Blood Loss During Vaginal Hysterectomy
Estimated Blood Loss
Estimated blood loss as mL
Secondary Outcome Measures
Operative Time and Complication Rates
Full Information
NCT ID
NCT00799292
First Posted
October 21, 2008
Last Updated
June 25, 2018
Sponsor
Ascher-Walsh, Charles, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00799292
Brief Title
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
Official Title
Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ascher-Walsh, Charles, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vasoconstrictive agents are increasingly being used in order to decrease blood loss during vaginal hysterectomy. The first reported study of the use of a vasoconstrictive agent for this purpose was on the use of epinephrine injected intracervically preoperatively by England, et. al. They demonstrated a significant decrease in the amount of blood lost during the surgery but also demonstrated a significant increase in the risk of post-operative infections, most frequently a vaginal cuff cellulitis requiring antibiotic treatment. Recent studies using vasopressin as the vasoconstrictive agent have also found the same significant decrease in blood loss while not demonstrating a difference in the rate of post-operative infections. The more recent studies by Speer and Unger , and Kammerer-Doak, et.al. were larger, better designed studies and are considered more credible. More surgeons are therefore injecting vasopressin intracervically preoperatively.
Some surgeons believe that the injection of vasopressin intracervically prior to the initial incision of a vaginal hysterectomy effects surgical plains and therefore makes the surgical dissection more difficult. This is thought to possibly both add to operative time and increase the rate of complications. The aforementioned studies used the injection of saline as a control for the injection of vasopressin or epinephrine. To date, no study has compared the use of vasopressin versus no injection in a controlled, randomized manner. We do not know if the injection of saline intracervically may actually increase the amount of bleeding over the baseline and therefore the decreased blood loss caused by the injection of vasopressin my actually be overestimated.
We propose to compare the effects of injecting vasopressin intracervically preoperatively versus no preoperative medication. We will not only evaluate the amount of operative blood loss, but also compare operative time and complication rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss During Vaginal Hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No injection
Arm Type
No Intervention
Arm Description
Patients did not receive an injection at cervix prior to beginning the procedure
Arm Title
Injection of vasopressin
Arm Type
Experimental
Arm Description
Patients will be randomized to receive 20cc of dilute vasopressin (20units in 50cc normal saline)injected at cervix at beginning of the hysterectomy
Intervention Type
Drug
Intervention Name(s)
Vasopressin
Intervention Description
20cc of dilute vasopressin (20units in 50cc normal saline). At beginning of the procedure 5cc injected were injected at 2,4,8 and 10 o'clock on the cervix
Primary Outcome Measure Information:
Title
Intra-operative Blood Loss During Vaginal Hysterectomy
Time Frame
Blood loss will be assessed at the end of the operative procedure
Title
Estimated Blood Loss
Description
Estimated blood loss as mL
Time Frame
Duration of vaginal hysterectomy
Secondary Outcome Measure Information:
Title
Operative Time and Complication Rates
Time Frame
Duration of procedures and immediate post-operative stay in hospital
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures
Exclusion Criteria:
women with a significant medical condition, including severe liver disease, congestive heart failure, documented coronary artery disease, impaired renal function determined by an elevated serum creatinine, asthma with steroid use in the past year, and migraines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ascher-Walsh, MD, MPH
Organizational Affiliation
Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19155900
Citation
Ascher-Walsh CJ, Capes T, Smith J, Michels A. Cervical vasopressin compared with no premedication and blood loss during vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2009 Feb;113(2 Pt 1):313-8. doi: 10.1097/AOG.0b013e3181954c44.
Results Reference
derived
Learn more about this trial
Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial
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