The aim of this study is to investigate the effects of Surgical versus medical treatment for abnormal uterine bleeding in premenopausal women. In this randomized clinical trial, 97 women premenopausal women, aged 40-55 years, with complaint of abnormal uterine bleeding were recruited. After obtaining informed concept, ultrasonography and endometrial biopsy or D&C were performed and atypical hyperplasia, uterine malignancy or organic disorders were ruled out. Then, the patients were randomly allocated to undergo abdominal hysterectomy or receiving diphereline, 3.75 mg IM every 28 days for 3 doses. All the patients were interviewed before intervention, 3 months, 6 months and 2 years after he interventions and improvement of uterine bleeding as early outcome and anemia and quality of life as secondary outcomes were evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103065563N3
Registration date:2011-03-24, 1390/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-24, 1390/01/04
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2007-05-13, 1386/02/23
Expected recruitment end date
2010-03-14, 1388/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical versus medical treatment for abnormal uterine bleeding in premenopausal women
Public title
Surgical versus medical treatment for abnormal uterine bleeding in premenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Premenopausal women between 40-55 years old with abnormal uterine bleeding for at least 2 months which is described as bleeding more than 7 days in a month or heavy bleeding resulting in anemia (Hct<32%), no evidence for atypical heperplasia or carcinoma in D&C, no response to simple medications such as medroxy progetrone and contraceptive tablets, no Ovarian or uterine organic lesions (ruled out by using clinical examination and ultrasonography)
Exclusion criteria: Anemia for other reasons, Fertility preservation, Evidence of pregnancy, Endocrinopathy, Coagulopathy, contraindications for medical treatment, Using IUD
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
97
Randomization (investigator's opinion)
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, Tabriz University of Medical Sciences
Street address
Golgasht Ave.
City
Tabriz
Postal code
Approval date
2006-11-02, 1385/08/11
Ethics committee reference number
6376/4/5
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
Uterine bleeding
Timepoint
before intervention, 2, 3 months and 2 years after intervention
Method of measurement
asking from patient
Secondary outcomes
1
Description
anemia
Timepoint
before intervention, 2, 3 months and 2 years after intervention
Method of measurement
Hb and Hct analysis
2
Description
quality of life
Timepoint
before intervention, 2, 3 months and 2 years after intervention
Method of measurement
WHOOQL standard questionaire
Intervention groups
1
Description
diphereline 3.75 mg IM every 28 days for 3 doses
Category
Treatment - Drugs
2
Description
standard surgical treatment (abdominal hysterectomy)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Elaheh ouladsahebmadarek
Street address
South Artesh Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Golgasht Ave.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
associate prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1553 9160
Fax
Email
elmadarek33@yahoo.comadarek@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
associate prof. of Ob & Gyn
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.
City
Tabriz
Postal code
Phone
+98 41 1554 1221
Fax
Email
elmadarek33@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)