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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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ClinicalTrials.gov Identifier: NCT00799292
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : November 27, 2008
Last Update Posted : July 24, 2018
Sponsor:
Information provided by:
Ascher-Walsh, Charles, M.D.

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.


Condition or disease Intervention/treatment Phase
Blood Loss During Vaginal Hysterectomy Drug: Vasopressin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy
Study Start Date : January 2004
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No injection
Patients did not receive an injection at cervix prior to beginning the procedure
Experimental: Injection of vasopressin
Patients will be randomized to receive 20cc of dilute vasopressin (20units in 50cc normal saline)injected at cervix at beginning of the hysterectomy
Drug: Vasopressin
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 Measures :
  1. Intra-operative Blood Loss During Vaginal Hysterectomy [ Time Frame: Blood loss will be assessed at the end of the operative procedure ]
  2. Estimated Blood Loss [ Time Frame: Duration of vaginal hysterectomy ]
    Estimated blood loss as mL


Secondary Outcome Measures :
  1. Operative Time and Complication Rates [ Time Frame: Duration of procedures and immediate post-operative stay in hospital ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799292


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Ascher-Walsh, Charles, M.D.
Investigators
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Principal Investigator: Charles Ascher-Walsh, MD, MPH Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Charles Ascher-Walsh MD, MPH, Mt Sinai School of Medicine, Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00799292    
Other Study ID Numbers: ASW 123
First Posted: November 27, 2008    Key Record Dates
Results First Posted: November 27, 2008
Last Update Posted: July 24, 2018
Last Verified: November 2008
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs