Combined Vaginal Misoprostol and Perivascular Vasopressin

• Status: Recruiting
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Arginine Vasopressin; Misoprostol; Vasopressins

Criteria

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