Combined Vaginal Misoprostol and Perivascular Vasopressin

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.

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