CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 152 enrolled
Drug / intervention
Vasopressindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01393704
NCT01393704Phase 4Completed

Vasopressin Administration During Laparoscopic Myomectomy: a Randomized Controlled Trial

Brigham and Women's Hospital·interventional·Posted Jul 13, 2011·Updated Feb 15, 2018

In Brief

A Phase 4 clinical trial evaluating Vasopressin for Blood Loss, Surgical. Completed, enrolled 152 participants across 1 site.

Detailed Summary

The main purpose of this study is to compare blood loss at the time of laparoscopic or robotically-assisted laparoscopic myomectomy when using different amounts of dilute vasopressin solution. Myomectomy is a surgical procedure to remove fibroids from the uterus. Vasopressin is a synthetic drug used to help decrease blood loss at the time of gynecologic surgery; although very little is know about the optimal dosage and administration. The investigators plan to perform a randomized clinical trial on patients scheduled for minimally invasive myomectomy. All patients will get the same overall amount of vasopressin. Patients will be assigned by chance to one of two groups: one group will receive higher volume of a more dilute vasopressin solution. The other group will receive a lower volume of a more concentrated solution. The investigators will collect information on operative blood loss and complications related to surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2011
Enrollment StartJul 1, 2011
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.0 years ago

Interventions

Vasopressindrug

Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.