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CompletedNCT00898170Updated May 12, 2009

Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

An interventional study of myoma removal in Myoma and Hypertension, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 22 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-05-12.

Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
22 Years to 55 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Myoma
  • Hypertension

Keywords

  • myoma
  • hypertension
  • erythropoetin
  • blood pressure
  • erythropoetin level
03

Who can participate

Ages eligible
22 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patient refusal
  • inoperable patients
  • other secondary cases of hypertension
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    myoma, with or without hypertension

    those with myoma with or without hypertension in holter monitoring

    Procedure: myoma removal

Interventions

  • Proceduremyoma removal

    surgical removal of myoma by hysterectomy

05

What researchers measure

Primary outcomes

  1. 24 hour holter monitoring of blood pressure

    Time frame: 6 weeks

Secondary outcomes

  1. erythropoetin level

    Time frame: 6 weeks

06

Study locations

1 site
  • Cardiology Ward Shiraz University of Medical Sciences
    Shiraz, Fars 51318, Iran, Islamic Republic of
07

Registry details

Key details

Study ID
NCT00898170
Lead sponsor
Shiraz University of Medical Sciences
First posted
May 12, 2009
Start date
May 2008
Primary completion
Mar 2009
Completion
Mar 2009
Last update
May 12, 2009

Study contacts

javad kojuri, M.D.
principal investigator · Shiraz University of Medical Sciences
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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