Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Hypertension Clinical Trial

Official title:

Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898170
• Other study ID #: 88-2505
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 11, 2009
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The effect of myoma removal was studied on 28 patients with hypertension and myoma by holter monitoring and erythropoetin level check.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 55 Years

Eligibility

Inclusion Criteria:

• candidate for myoma removal by hysterectomy

• operable

• hysterectomy is indicated

Exclusion Criteria:

• patient refusal

• inoperable patients

• other secondary cases of hypertension

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Myoma

Intervention

Procedure:
• myoma removal
surgical removal of myoma by hysterectomy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Cardiology Ward Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour holter monitoring of blood pressure		6 weeks	No
Secondary	erythropoetin level		6 weeks	No