MedTrace Logo

Combined Vaginal Misoprostol and Perivascular Vasopressin

NCT03815344 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-01-09

Study results available
· View outcomes & findings →

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

Interventions

DRUG

Standard

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

DRUG

Standard-vaginal misoprostol

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

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Pedram Bral, M.D. · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815344 on ClinicalTrials.gov