Comparing of bleeding and dysmenorrhea with Multi Load CU 375 and CU 380A intrauterine device in women referred to health centers in Tabriz:A randomized Clinical Trial.
The aim of this randomized controlled trial ( double blind ) is comparing the bleeding and dysmenorrhea in multi-load 375 and copper T 380 A IUD. We will recruit 48 women 15-45 years old at selected public health center in Tabriz/Iran who have no IUD contraindication and their pain score intensity based on Visual Analoge Scale is below 7 at the time of menstruation. After getting written informed consent, participants will complete demographic characteristics questionnaire and Higham table according to their degree of bleeding and Visual Analog Scale according to pain intensity during menstruation one month before IUD insertion. Then we will randomly allocate them into intervention and control groups using permuted block randomization with block sizes of 4 and 6 concealed in sequentially numbered, sealed, opaque envelopes. IUD insertion immediately after menstrual bleeding will be done. In each menstrual cycle the participants will be asked through phone contact to record the amount of bleeding with Higham table and pain using Visual Analoge Scale during menstruation, in four cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109176709N5
Registration date:2012-02-01, 1390/11/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-02-01, 1390/11/12
Registrant information
Name
Mahnaz Shahnazi
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
mshahnazi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of bleeding and dysmenorrhea with Multi Load CU 375 and CU 380A intrauterine device in women referred to health centers in Tabriz:A randomized Clinical Trial.
Public title
Comparing of bleeding and menstrual pain with two types of intrauterine device
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The age range is 15 to 45 years; No contraindications IUD insertion including: Pregnancy, puerperium sepsis, pelvic inflametory disease or sexually trasmitted infections (currently or in the past 3 months), uterin or cervical cance,unknown genital bleeding, uterin abnormality and fibroid
tumors causing deformity in uterus and Wilson's disease; N0 use of hormonal methods of contraception (DMPA in the past one year and OCP, cyclofem in the past 3 months); Delivery time is at least 6 months; score their pain intensity based on Visual Analoge Scale is below 7 at the time of menstruation. Exclusion criteria: Problem in IUD insertion.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
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
Research Deputy of Tabriz University of Medical Sciences
Street address
Golgasht St/Tabriz
City
Tabriz
Postal code
51665118
Approval date
2012-01-02, 1390/10/12
Ethics committee reference number
9069
Health conditions studied
1
Description of health condition studied
Comparing bleeding and dysmenorrhea with two types of IUD
ICD-10 code
Z30.1
ICD-10 code description
Insertion of (intrauterine) contraceptive device
Primary outcomes
1
Description
Bleeding of IUD insertion
Timepoint
One month before and four months after IUD insertion
Method of measurement
Higham table
Secondary outcomes
1
Description
Dysmenorrhea of IUD insertion
Timepoint
One month before and four months after IUD insertion
Method of measurement
Visual Analoge Scale
Intervention groups
1
Description
Intervention group: Group receiving the multi-load 375 IUD
Category
Prevention
2
Description
Control group: Group receiving the coppr T 380A IUD
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bavafa health center
Full name of responsible person
Somayyeh Sarrafi Kheirabad
Street address
Monajjem blvd, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Golgashat Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Somayyeh Sarrafi Kheirabad
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
South shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
51745347
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
somayyeh.sarrafi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Shahnazi
Position
Master of Sciences of Midwifery
Other areas of specialty/work
Street address
South Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
+98 41 1479 6969
Email
mshahnazi@Tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somayyeh Sarrafi Kheirabad
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
South Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
5615751147
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
somayyeh.sarrafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)