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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
This study has been completed.
First Received: October 21, 2008   Last Updated: November 26, 2008   History of Changes
Sponsored by: Ascher-Walsh, Charles, M.D.
Information provided by: Ascher-Walsh, Charles, M.D.
ClinicalTrials.gov Identifier: NCT00799292
  Purpose

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 Intervention Phase
Blood Loss During Vaginal Hysterectomy
Drug: Vasopressin
Other: No injection
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy

Resource links provided by NLM:


Further study details as provided by Ascher-Walsh, Charles, M.D.:

Primary Outcome Measures:
  • Intra-Operative Blood Loss During Vaginal Hysterectomy [ Time Frame: Blood loss will be assessed at the end of the operative procedure ] [ Designated as safety issue: Yes ]
  • Estimated Blood Loss [ Time Frame: Duration of vaginal hysterectomy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Operative Time and Complication Rates [ Time Frame: Duration of procedures and immediate post-operative stay in hospital ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: January 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No injection: No Intervention
Patients did not receive an injection at cervix prior to beginning the procedure
Other: No injection
Patients did not receive an injection of medication at cervix prior to beginning of procedure
Injection of vasopressin: Experimental
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799292

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Ascher-Walsh, Charles, M.D.
Investigators
Principal Investigator: Charles Ascher-Walsh, MD, MPH Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
  More Information

No publications provided by Ascher-Walsh, Charles, M.D.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Mt Sinai School of Medicine, Department of Obstetrics and Gynecology ( Charles Ascher-Walsh MD, MPH )
Study ID Numbers: ASW 123
Study First Received: October 21, 2008
Results First Received: October 21, 2008
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00799292     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Arginine Vasopressin
Arginine
Vasoconstrictor Agents
Vasopressins
Cardiovascular Agents
Hemorrhage
Hemostatics

Additional relevant MeSH terms:
Coagulants
Physiological Effects of Drugs
Hematologic Agents
Cardiovascular Agents
Hemorrhage
Hemostatics
Pharmacologic Actions
Arginine Vasopressin
Pathologic Processes
Natriuretic Agents
Therapeutic Uses
Vasopressins
Vasoconstrictor Agents
Antidiuretic Agents

ClinicalTrials.gov processed this record on September 10, 2009