NCT02377492

Brief Summary

The goal of the investigators study is to evaluate the effectiveness of paracervical injection of vasopressin at the time of abdominal myomectomy to decrease blood loss. The investigators will continue to use intramyometrial vasopressin as this has previously been shown to be effective. The study will not exceed the safely documented dose of vasopressin.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

February 25, 2015

Last Update Submit

May 6, 2022

Conditions

Myoma

Outcome Measures

Primary Outcomes (1)

  • 1. Estimating blood loss at the end of myomectomy (calculated as [total suction canister volume] +[laparotomy pads] - [volume of irritation used] - [volume of vasopressin used])

    1 day

Secondary Outcomes (3)

  • Change in Hgb and Hct post-operatively from pre-operative level

    1- 2 days

  • Peri-operative complications

    2 days

  • Total operation time (time from incision to end of surgery)

    1 day

Study Arms (2)

Paracervical & Intramyometrial

EXPERIMENTAL

Vasopressin will be placed paracervically (8mL, 4 units) and intramyometrial (8mL, 4 units)

Drug: Vasopressins

Intramyometrial

ACTIVE COMPARATOR

Vasopressin will be placed intramyometrial (16mL, 8 units)

Drug: Vasopressins

Interventions

VasopressinsDRUG

Either paracervical and intramyometrial or intramyometrial alone at time of abdominal myomectomy.

Also known as: vasopressin
IntramyometrialParacervical & Intramyometrial

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years old
  • All women who are candidates for abdominal myomectomy and are willing to accept randomization

You may not qualify if:

  • Patients unable to consent for the study
  • Suspected malignancy
  • History of adverse reaction or allergy to vasopressin
  • Active cardiovascular or pulmonary disease that would indicate a contraindication to use of vasopressin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Fertility Center

Beachwood, Ohio, 44122, United States

Location

University Hospitals

Cleveland, Ohio, 44117, United States

Location

MeSH Terms

Conditions

Myoma

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

US(2)