Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

• Sponsor: Shiraz University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00898170
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myoma; Hypertension	Procedure: myoma removal	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Effect of Myoma Removal on Blood Pressure and Erythropoetin Level
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: myoma, with or without hypertension those with myoma with or without hypertension in holter monitoring	Procedure: myoma removal; surgical removal of myoma by hysterectomy

Outcome Measures

Primary Outcome Measures

1. 24 hour holter monitoring of blood pressure [6 weeks]

Secondary Outcome Measures

1. erythropoetin level [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• candidate for myoma removal by hysterectomy

• operable

• hysterectomy is indicated

Exclusion Criteria:

• patient refusal

• inoperable patients

• other secondary cases of hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology Ward Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of	51318

Sponsors and Collaborators

• Shiraz University of Medical Sciences

Investigators

• Principal Investigator: javad kojuri, M.D., Shiraz University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00898170
• Other Study ID Numbers: 88-2505
• First Posted: May 12, 2009
• Last Update Posted: May 12, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: myoma; hypertension; erythropoetin; blood pressure; erythropoetin level
• Additional relevant MeSH terms: Myoma; Hypertension

Study Results

No Results Posted as of May 12, 2009