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

NCT00799292 | Completed Phase 4 Results

• 1 other identifier: ASW 123
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Loss During Vaginal Hysterectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Operative Time and Complication Rates

  Duration of procedures and immediate post-operative stay in hospital

Study Arms (2)

No injection

NO INTERVENTION

Patients did not receive an injection at cervix prior to beginning the 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

Interventions

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

Injection of vasopressin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women greater that 18 undergoing vaginal hysterectomy for any indication, with or without concomitant procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascher-Walsh, Charles, M.D.: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 19155900 DERIVED

MeSH Terms

Interventions

Vasopressins

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Charles Ascher-Walsh MD, MPH
• Organization: Mt Sinai School of Medicine, Department of Obstetrics and Gynecology

charles.ascher-walsh@mssm.edu

212-241-2827

Study Officials

• Charles Ascher-Walsh, MD, MPH

  Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: November 27, 2008
• Study Start: January 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: July 24, 2018
• Results First Posted: November 27, 2008

Record last verified: 2008-11

Locations

US (1)