Combined Vaginal Misoprostol and Perivascular Vasopressin

NCT03815344 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-03-09
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leiomyoma; Laparoscopy; Uterine Myomectomy

Keywords

Robot-assisted; Laparoscopic; vasopressin; misoprostol; blood loss

Outcome Measures

Primary Outcomes (1)

• Hemoglobin Levels Difference Between Pre and Post Surgery.

  The difference in hemoglobin levels between pre surgery and post surgery

  1 hour

Study Arms (2)

Standard

ACTIVE COMPARATOR

Use of laparoscopic injection of diluted vasopressin (20units in 100mL 0.9NS) prior to incision throughout the myomectomy.

Drug: Standard-vaginal misoprostol

Standard-Vaginal Misoprostol

EXPERIMENTAL

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; Drug: Standard-vaginal misoprostol

Interventions

Standard DRUG

20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Also known as: Perivascular vasopresssin

Standard-Vaginal Misoprostol

Standard-vaginal misoprostol DRUG

20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg

Also known as: perivascular vasopresssin-vaginal misprostol

Standard; Standard-Vaginal Misoprostol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of adverse reaction or allergy to Vasopressin.
• History of adverse reaction or allergy to Misoprostol.
• Medical contraindication to use of Vasopressin or Misoprostol
• Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
• 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.
• 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.
• Pregnant women

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (5)

• Iavazzo C, Mamais I, Gkegkes ID. Use of misoprostol in myomectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2015 Dec;292(6):1185-91. doi: 10.1007/s00404-015-3779-x. Epub 2015 Jun 4.

  PMID: 26041328 RESULT

• Kalogiannidis I, Xiromeritis P, Prapas N, Prapas Y. Intravaginal misoprostol reduces intraoperative blood loss in minimally invasive myomectomy: a randomized clinical trial. Clin Exp Obstet Gynecol. 2011;38(1):46-9.

  PMID: 21485725 RESULT

• Buttram VC Jr, Reiter RC. Uterine leiomyomata: etiology, symptomatology, and management. Fertil Steril. 1981 Oct;36(4):433-45. doi: 10.1016/s0015-0282(16)45789-4.

  PMID: 7026295 RESULT

• Cohen SL, Senapati S, Gargiulo AR, Srouji SS, Tu FF, Solnik J, Hur HC, Vitonis A, Jonsdottir GM, Wang KC, Einarsson JI. Dilute versus concentrated vasopressin administration during laparoscopic myomectomy: a randomised controlled trial. BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.

  PMID: 27362908 RESULT

• Kongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5.

  PMID: 25125317 RESULT

Related Links

• FDA website

MeSH Terms

Conditions

Leiomyoma; Diabetes Insipidus; Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pedram Bral, MD
• Organization: Maimonides Medical Center

pbral@maimonidesmed.org

7182836000

Study Officials

• Pedram Bral, M.D.

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: January 24, 2019
• Study Start: April 26, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)