Skip to main content
OpenTrials
Completed

NCT Number: NCT00799292

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasopressin

Drug

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 outcomes

  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 outcomes

  1. Operative Time and Complication Rates

    Time frame: Duration of procedures and immediate post-operative stay in hospital

Sponsors and collaborators

Lead sponsor

Ascher-Walsh, Charles, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 27, 2008
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.