1. Home
  2. Approved trials
  3. » فارسی

Comparison of two kinds of treatment with thermal balloon and hysteroscopy in the treatment of abnormal uterine bleeding

Protocol summary

Summary
Menorrhagia is one of the most common reasons for referral to gynecologists. Many women do not respond to medical treatment and are candidate for hysterectomy. Some of them who are in their middle age don’t like to have hysterectomy and those who are older are not candidate for medical treatment and surgical hysterectomy due to internal diseases in this age. So, endometrial ablation is one of suggested treatments. This clinical trial will be done on women with menorrhagia who have not responded to medical treatment. Patients are categorized into two groups: endometrial ablation with thermal balloon (intervention group, 35 patients) and endometrial ablation with hysteroscopy (control group, 25 patients). Information such as age, parity, BMI, dysmenorrhea, menstrual period, duration of menorrhagia, treatment taken, medical history, underlying disease, history of previous surgery will be recorded. Postoperative complications of hysteroscopy including bleeding, infection, uterine perforation, thermal injury, and complications after thermal balloon including thermal injury to the bowel, bleeding, uterine perforation, adenexal necrosis are recorded. All patients are followed for one year. Outcomes for each patient will be recorded for 6 months and 12 months after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207163820N5
Registration date: 2012-08-18, 1391/05/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-18, 1391/05/28
Registrant information
Name
Zinatalsadat Bouzari
Name of organization / entity
Babol university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4651
Email address
z_b412003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Expected recruitment start date
2011-11-09, 1390/08/18
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two kinds of treatment with thermal balloon and hysteroscopy in the treatment of abnormal uterine bleeding
Public title
Treatment of abnormal uterine bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - no response to treatment; 2 - lack of desire for fertility and having children; 3 - normal cervical cytology; 4 - normal endometrial histology. Exclusion criteria: 1 - intrauterine pathologies (such as polyps or submocusal fibroma); 2 - Uterine cavity length more than 12 cm; 3 - hyperplasia or endometrial atypy.
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)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
6646

Health conditions studied

1

Description of health condition studied
Abnormal uterine bleeding
ICD-10 code
N93.8
ICD-10 code description
Other specified abnormal uterine and vaginal bleeding

Primary outcomes

1

Description
The amount of vaginal bleeding
Timepoint
6 month and 12 month
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Perforation of the uterus after treatment
Timepoint
Intraoperative
Method of measurement
Clinical

2

Description
Uterine infection after treatment
Timepoint
7-3 days after intervention
Method of measurement
Clinical

Intervention groups

1

Description
Frist group:treatment with tharmal balloon, Intervention group
Category
Treatment - Surgery

2

Description
Second group:treatment with hysteroscop, control group
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatolah Rohani Hospital
Full name of responsible person
Dr. Zinatossadat Bouzari
Street address
Rohani Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Gangafroz Avenue
City
Babol
Grant name
.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and technology, Babol 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
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
DR. Zinatossadat Bouzari
Position
Assistant professor
Other areas of specialty/work
Street address
Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
+98 11 1223 8317
Email
z_b412003@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Shahla Yazdani
Position
Assistant professor
Other areas of specialty/work
Street address
Rohani Hospital
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
Email
shahla_yazdani_1348@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Research Center, Noshirvani street
City
Babol
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...