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Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Primary Purpose

Myoma, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
myoma removal
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myoma focused on measuring myoma, hypertension, erythropoetin, blood pressure, erythropoetin level

Eligibility Criteria

22 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • candidate for myoma removal by hysterectomy
  • operable
  • hysterectomy is indicated

Exclusion Criteria:

  • patient refusal
  • inoperable patients
  • other secondary cases of hypertension

Sites / Locations

  • Cardiology Ward Shiraz University of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

myoma, with or without hypertension

Arm Description

those with myoma with or without hypertension in holter monitoring

Outcomes

Primary Outcome Measures

24 hour holter monitoring of blood pressure

Secondary Outcome Measures

erythropoetin level

Full Information

First Posted
May 11, 2009
Last Updated
May 11, 2009
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00898170
Brief Title
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level
Official Title
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.
Detailed Description
Background: Myoma is the most common gynecoid tumor and produces many vasoactive substances, which may be a cause for secondary hypertension. Early reports suggested the association of myoma and hypertension. We studied the effect of myoma removal on hypertension and erythropoietin level to evaluate this hypothesis. Patients & Methods: In this single centered prospective cohort study, in twenty eight patients who were candidates for myomectomy due to myoma, 24 hour holter monitoring of blood pressure and serum erythropoietin were checked before and 6 weeks after hysterectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myoma, Hypertension
Keywords
myoma, hypertension, erythropoetin, blood pressure, erythropoetin level

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myoma, with or without hypertension
Arm Type
Experimental
Arm Description
those with myoma with or without hypertension in holter monitoring
Intervention Type
Procedure
Intervention Name(s)
myoma removal
Intervention Description
surgical removal of myoma by hysterectomy
Primary Outcome Measure Information:
Title
24 hour holter monitoring of blood pressure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
erythropoetin level
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: candidate for myoma removal by hysterectomy operable hysterectomy is indicated Exclusion Criteria: patient refusal inoperable patients other secondary cases of hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
javad kojuri, M.D.
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Ward Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
51318
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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