Effect of Myoma Removal on Blood Pressure and Erythropoet... | NCT00898170

Studies
Effect of Myoma Removal on Blood Pressure and Erythropoetin Level

NCT00898170

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

May 12, 2009Estimated

Enrollment

28Actual

Phase

Not Applicable

Conditions

Myoma
Hypertension

Interventions

myoma removal

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 11, 2009

First Posted Date

May 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2009

Last Update Posted Date

May 12, 2009Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
myoma, with or without hypertension	Experimental	those with myoma with or without hypertension in holter monitoring	Procedure: myoma removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myoma removal	Procedure	surgical removal of myoma by hysterectomy	myoma, with or without hypertension

Measure	Description	Time Frame
24 hour holter monitoring of blood pressure		6 weeks

Measure	Description	Time Frame
erythropoetin level		6 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
javad kojuri, M.D.	Shiraz University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Ward Shiraz University of Medical Sciences		Shiraz	Fars	51318	Iran

Condition Browse Module

MeSH Terms

ID	Term
D009214	Myoma
D006973	Hypertension

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided