Comparison of the Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy: A Randomized, Placebo Controlled Trial

Effects of Cervical Vasopressin Versus no Premedication on Blood Loss During Vaginal Hysterectomy

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss During Vaginal Hysterectomy
• Intervention / Treatment: Drug: Vasopressin

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative Blood Loss During Vaginal Hysterectomy		Blood loss will be assessed at the end of the operative procedure
Estimated Blood Loss	Estimated blood loss as mL	Duration of vaginal hysterectomy

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative Time and Complication Rates	Duration of procedures and immediate post-operative stay in hospital

Collaborators and Investigators

• Sponsor: Ascher-Walsh, Charles, M.D.
• Investigators: Principal Investigator: Charles Ascher-Walsh, MD, MPH, Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2005
• Study Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: October 21, 2008
• First Submitted That Met QC Criteria: November 26, 2008
• First Posted (Estimate): November 27, 2008

Study Record Updates

• Last Update Posted (Actual): July 24, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: ASW 123