Determination of relative frequency of amenorrhea, oligomenorrhea and polymenorrhea and control of bleeding and complications and efficacy after embolization of uterine artery with foam polyvinyl alcohol gel.
Design
Eligible patients enter the study by completing the consent form. Information including age, type of delivery, fetal weight, gestational age, number of children and the cause of uterine artery embolization and the type of material used for embolization (foam gel or polyvinyl alcohol) will be extracted from patients according to the checklist.The effectiveness of the menstrual pattern will be questioned by the researcher during a telephone call with patients after 6 months. After collecting the study data, it is entered into the computer and analyzed by SPSS software version 20.
Settings and conduct
In the angiography unit of Al-Zahra and Khorshid hospitals, embolization of the uterine artery with foam gel or polyvinyl alcohol is performed for patients with postpartum hemorrhage.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1 Patients with postpartum hemorrhage undergoing treatment of uterine artery embolization.
2 Patient consent to enter the study.
Non-entry criteria:
Patients who have undergone uterine artery embolization for other reasons, including uterine myoma, uterine fibroids, and false uterine aneurysms.
Intervention groups
70 patients who referred to the educational and medical centers of Isfahan University of Medical Sciences in the years 1398 to 1399 due to postpartum hemorrhage and have been treated for uterine artery embolization. They are studied by census method.
Main outcome variables
Amenorrhea, polymenorrhea, oligomenorrhea, complications of uterine artery embolization and type of embolization material.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200221046569N1
Registration date:2020-09-12, 1399/06/22
Registration timing:retrospective
Last update:2020-09-12, 1399/06/22
Update count:0
Registration date
2020-09-12, 1399/06/22
Registrant information
Name
Soheila Aghataheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
mehrdadghafari1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and complications of uterine artery embolization in patients with postpartum hemorrhage
Public title
Examination of menstrual pattern in people who have had uterine artery embolization to control postpartum hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have had postpartum hemorrhage and have been treated for uterine artery embolization
Exclusion criteria:
Patients who have undergone uterine artery embolization for other reasons, including uterine myoma, uterine fibroids, and false uterine aneurysms.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
No. 87, Sub-street 7, Amirieh alley
City
Esfahan
Province
Isfehan
Postal code
8174957797
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.MUI.MED.REC.1398.372
Health conditions studied
1
Description of health condition studied
Postpartum hemorrhage
ICD-10 code
o72.2
ICD-10 code description
Delayed and secondary postpartum haemorrhage
Primary outcomes
1
Description
Percentage of patients improved
Timepoint
3 and 6 months after embolization
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with foam and polyvinyl alcohol undergoing uterine artery embolization through the femoral artery are performed in the angiography department of Al-Zahra and Khorshid hospitals, where the amount of material consumed varies from person to person.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital.
Full name of responsible person
Soheila Aghatahri.
Street address
No. 87, Sub-Unit 7, 5th Street, Amirieh Alley, Unit 6
City
Esfahan
Province
Isfehan
Postal code
8174957797
Phone
+98 31 3781 3837
Email
mehrdadghafari1@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezar Jerib Avenue
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Aghatahri.
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Thousand acres of streets.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mehrdadghafari1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Aghatahri .
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Thousand acres of streets.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mehrdadghafari1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Soheila Aghatahri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Thousand acres of streets.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
mehrdadghafari1@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Total potential data after unidentifiable individuals.
When the data will become available and for how long
After printing the results.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Committed and expert researchers who use the results of the study to treat patients.
From where data/document is obtainable
Dr. Soheila Aghataheri Department of Obstetrics and Gynecology, Al-Zahra Hospital
What processes are involved for a request to access data/document