Combined Vaginal Misoprostol and Perivascular Vasopressin

January 8, 2024 updated by: Antonios Likourezos

A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy

Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain, and infertility. While hysterectomy with removal of the uterus is standard of care for symptomatic uterine fibroids, women desiring future child bearing require removal of the fibroids alone via uterine myomectomy, with re-construction of the uterus after removal. A well established risk to such a procedure is the operative blood loss, which can be quite significant due to the increased blood supply fibroids accumulate. Several interventions have been looked at as potential methods to help decrease operative blood loss. Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. A known potential side effect of vasopressin is cardiovascular compromise, which can be catastrophic if vasopressin is inadvertently injected into the large vessels of the uterus. This limits the amount that can be safely used in surgery. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus. While Vasopressin is more commonly used during surgery, the associated potential risks limit the amount that can be safely administered. However, the addition Misoprostol, with a relatively safe side effect profile, can further improve control of the blood supply and decrease operative blood loss. Misoprostol can be administered orally, sublingually, or as vaginal or rectal suppositories. While the systemic absorption of vaginal Misoprostol is slower in onset than the oral or sublingual routes, the effect is maintained for a longer period of time, and is more conducive to use during laparoscopic or robotic assisted myomectomies given the prolonged operative time associated with minimally invasive techniques when compared to traditional open approaches. This study aims to determine whether using vaginal Misoprostol in combination with Vasopressin is more effective at decreasing operative blood loss during robotic assisted laparoscopic myomectomy than Vasopressin alone.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.

Exclusion Criteria:

  1. History of adverse reaction or allergy to Vasopressin.
  2. History of adverse reaction or allergy to Misoprostol.
  3. Medical contraindication to use of Vasopressin or Misoprostol
  4. Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
  5. Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
  6. Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
  7. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard
Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.
Drug: Standard-vaginal misoprostol
20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Other Names:
  • perivascular vasopresssin-vaginal misprostol
Experimental: Standard-Vaginal Misoprostol
Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy. 400mcg of misoprostol placed in the vagina at HUMI/foley placement .
Drug: Standard-vaginal misoprostol
20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
Other Names:
  • perivascular vasopresssin-vaginal misprostol
Drug: Standard
20 units diluted in 100mL of Normal Saline injected laparoscopic needle
Other Names:
  • Perivascular vasopresssin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Levels Difference Between Pre and Post Surgery.
Time Frame: 1 hour
The difference in hemoglobin levels between pre surgery and post surgery
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Operative Time
Time Frame: 0 hours up to 24 hours
Total time of the robotic assisted laparoscopic myomectomy
0 hours up to 24 hours
Side Effects
Time Frame: 0 hours up to 24 hours
Side Effect profile for Misoprostol Use
0 hours up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Investigators

  • Principal Investigator: Pedram Bral, M.D., Maimonides Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

January 20, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-03-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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