The purpose of this study is to evaluate the efficacy and complications of uterine artery embolization in patients with symptomatic uterine fibroids. This study is a clinical trial which is not blinded. 97 women with symptomatic uterine fibroids who referred to Imam Reza hospital or maternity clinics are selected through available method. Before treatment, the patients are imaged with MRI and the size, location, and type of fibroids are determined, as well as sonography is performed to determine the uterine volume and a blood sample is taken to check CBC diff, Bun / Cr, PTT / PT. Then a Cobra 5 F catheter enters into the common femoral artery through a small incision on the skin of the groin and is placed in the distal of uterine artery where the artery is became transverse and the right and left uterine arteries are catheterized selectively and embolic material is injected into these arteries, which leads to arteries blockage. Then, the catheter is removed after 60 minutes and the site is packed for 6 hours. The patient is controlled from bleeding of the catheterization site for one night and then can be discharged. The patients are evaluated 3, 6 and 12 months after embolization (UAE) with MRI, ultrasound and questionnaire in terms of response to treatment. Inclusion criteria: written consent of the patient; women with symptomatic uterine fibroids; candidate of hysterectomy or myomectomy. Exclusion criteria: no menopause, ovarian tumors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012714333N16
Registration date:2014-02-12, 1392/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of efficacy and complications of uterine artery embolization in patients with symptomatic uterine fibroids
Public title
The study of efficacy and complications of uterine artery embolization in patients with symptomatic uterine fibroids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: written consent of the patient; women with symptomatic uterine fibroids; candidate of hysterectomy or myomectomy. Exclusion criteria: no menopause, ovarian tumors.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
97
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2012-12-29, 1391/10/09
Ethics committee reference number
45277/پ/7/420
Health conditions studied
1
Description of health condition studied
utrine fibroids and bleeding
ICD-10 code
N85.8
ICD-10 code description
Other specified noninflammatory disorders of uterus
Primary outcomes
1
Description
Type of fibroids
Timepoint
Baseline and 3, 6 and 12 months after embolization (UAE)
Method of measurement
MRI
2
Description
Uterine size
Timepoint
Baseline and 3, 6 and 12 months after embolization (UAE)
Method of measurement
Sonography
3
Description
Clinical symptoms
Timepoint
3, 6 and 12 months after embolization (UAE)
Method of measurement
Based on questionnaire
4
Description
Fibroid size
Timepoint
Baseline and 3, 6 and 12 months after embolization (UAE)
Method of measurement
MRI
5
Description
Permanent amenorrhea
Timepoint
Baseline and 3, 6 and 12 months after embolization (UAE)
Method of measurement
Asking the patient
6
Description
Continuous vaginal discharge
Timepoint
3, 6 and 12 months after embolization (UAE)
Method of measurement
Asking the patient
7
Description
Recurrence of fibroids
Timepoint
3, 6 and 12 months after embolization (UAE)
Method of measurement
MRI
Secondary outcomes
empty
Intervention groups
1
Description
In the study group , a catheter enters into the common femoral artery through a small incision on the skin of the groin and is placed in the distal of uterine artery where the artery is became transverse and the right and left uterine arteries are catheterized selectively and embolic material is injected into these arteries, which leads to arteries blockage. Then, the catheter is removed after 60 minutes and the site is packed for 6 hours
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr.Mojgan Ayazi
Street address
Emam Reza Hospital,Razi Boulevard,Sorkhleje
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Nasrin Jalilian
Position
Special of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Emam Reza Hospital,Razi Boulevard,Sorkhleje
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
njalilian@kums.ac.irnjalilian@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)