Comparison of short-term complications (mensturation patern), satisfaction and quality of life in Mirena users as a contraception method with Copper IUD users
Background: Complications of IUDs are the main reasons why women discontinue this effective contraception method. There are possible differences in the complications of copper and Levonorgetrol-releasing IUDs Mirena that affect which IUD to select. This study is designed to compare the short-term complications, satisfaction and quality of life of these two types of IUDs.
Methods: This double-blinded clinical trial will be done on 160 women of 20-35 years old referring to Ayat Health Center for IUD contraception. By block randomization, cases will be divided into two groups: Levonorgetrol IUD, 80 individuals in group A (Mirena, Shering Company, Germany) and 80 invdividuals in Copper 380-A IUD, group B (India). In the initial visit and 1, 3 and 6 months follow-ups, short-term complications will be assessed by a gynecologist.Quality of life and satisfaction will be assessed by sf36 questionnaire and asking 3 questions respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903013881N2
Registration date:2011-10-21, 1390/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-21, 1390/07/29
Registrant information
Name
Toktam Tavakolianfar
Name of organization / entity
Islamic Azad University, Neyshabur Branch
Country
Iran (Islamic Republic of)
Phone
+98 55 1662 1905
Email address
tavakolianfar@iau-neyshabur.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Tehran University of Medical Sciences
Expected recruitment start date
2004-12-31, 1383/10/11
Expected recruitment end date
2005-12-31, 1384/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short-term complications (mensturation patern), satisfaction and quality of life in Mirena users as a contraception method with Copper IUD users
Public title
Contraception method IUD,copper IUD and mirena
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age20-35; normal menstruation; multi-parity and a negative pop smear result in the previous six months. Exclusion criteria: pregnancy; abnormal menstruation (irregularity, oligomenorrhea, hypermenorrhea and menorrhagia); malignancies of uterine; ovaries and breasts; a personal and familial history of mass in breasts; uterine anomaly or myoma; pelvic inflammatory disease; psychiatric disorders; Body mass index more than 32; multi-partnership of the individual or her spouse; chronic systemic diseases including renal failure; hepatic cirrhosis; and cardiovascular diseases; consumption of drugs related to the cardiovascular diseases
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 of Tehran University of Medical Sciences
Street address
Ghods st, Keshavarz blvd
City
Tehran
Postal code
14194
Approval date
2004-03-07, 1382/12/17
Ethics committee reference number
1539/ 2004
Health conditions studied
1
Description of health condition studied
Sequelae of complication of pregnancy, childbirth and the puerperium
ICD-10 code
O98
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
dysmenorrehea
Timepoint
frist visit and 1,3,6 months after IUD insertion
Method of measurement
questionnare
2
Description
quality of life
Timepoint
first visit before IUD insertion and 6 months after iud insertion
Method of measurement
questionnare
Secondary outcomes
1
Description
menorrhagia
Timepoint
1,3,6 month after iud insertion
Method of measurement
questionnare
2
Description
headache
Timepoint
1,3,6 month after iud insertion
Method of measurement
questionnare
3
Description
backpain
Timepoint
1,3,6 month after iud insertion
Method of measurement
questionnare
4
Description
breast tenderness
Timepoint
1,3,6 months after iud insertion
Method of measurement
questionnare
5
Description
spoting
Timepoint
1,3,6 months after iud insertion
Method of measurement
questionnare
6
Description
discharge
Timepoint
1,3,6 months after iud insertion
Method of measurement
questionnare
7
Description
stisfaction
Timepoint
6 months after iud insertion
Method of measurement
questionnare
8
Description
ackne
Timepoint
1,3,6 months after iud insertion
Method of measurement
questionnare
9
Description
weight gain
Timepoint
1,3,6 months after iud insertion
Method of measurement
questionnare
Intervention groups
1
Description
copper IUD
Category
Prevention
2
Description
mirena IUD
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ayat center
Full name of responsible person
Toktm Tavakolianfar
Street address
Islamic azad university Neyshabur branch
City
Neyshabur
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Ramezanzadeh
Street address
Keshavarz blvd
City
Tehran
Grant name
1539/ 2004
Grant code / Reference number
3000000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran 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
Islamic Azad University, Neyshabur Branch
Full name of responsible person
Toktam Tavakolianfar
Position
Msc, member of faculty
Other areas of specialty/work
Street address
Department of Midwifery, Neyshabur Branch, Islamic Azad university
City
Neyshabur
Postal code
9319613668
Phone
+98 55 1662 1904
Fax
+98 55 1661 5472
Email
tavakolianfar@iau-neyshabur
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Neyshabur Branch
Full name of responsible person
Toktam Tavakolianfar
Position
Msc, member of faculty
Other areas of specialty/work
Street address
Department of Midwifery, Neyshabur Branch, Islamic Azad university
City
Neyshabur
Postal code
00985519319613668
Phone
+98 55 1662 1904
Fax
+98 55 1661 5472
Email
tavakolianfar@iau-neyshabur.ac.ir
Web page address
www.iau-neyshabur.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Toktam Tavakolianfar
Position
Msc, member of feculty
Other areas of specialty/work
Street address
Department of Midwifery, Neyshabur Branch, Islamic Azad university
City
Neyshabur
Postal code
9319613668
Phone
+98 55 1662 1904
Fax
+98 55 1661 5472
Email
tavakolianfar@iau-neyshabur.ac.ir
Web page address
www.iau-neyshabur.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)