Overall objective: To determine the effect of oral contraceptives on disease activity in women with rheumatoid arthritis referred to selected rheumatology centers in Tehran.
Specific objectives: 1. Comparison of disease activity at enrollment and after 8 weeks in case group 2. Comparison of disease activity at enrollment and two months after that in control group 3. Comparison of disease activity between two groups after 8 weeks.
Design: Randomized controlled clinical trial
Method: consult with qualified women in the study, informed consent to participate in the study, randomly allocated in case (receiving oral contraceptive pills group) and control groups, determination of rheumatoid arthritis disease activity at the beginning of the study in two groups, administered intermittently oral contraceptive pills for 8 weeks in case group with onset of the first menstrual cycle (3 weeks administration and one week off and then start again the second box at the fifth week) and routine follow up in the control group, determination of disease activity in both groups again, compared The two groups regarding to study specific goals.
Samples: one hundred women of reproductive age (50 people in case group and 50 people in control group) who married and want to use oral contraceptives and are receiving medical treatment for rheumatoid arthritis disease and also didn’t use oral contraceptive pills during past 6 months.
Interventions: Administration of oral contraceptives for 8 weeks of intermittent in case group and no intervention in control group.
Consequences: disease activity of rheumatoid arthritis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904224364N1
Registration date:2011-07-24, 1390/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-24, 1390/05/02
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
amini@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Tehran University of Medical Sciences
Expected recruitment start date
2010-08-06, 1389/05/15
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral Contraceptive Pills on Disease Activity in Women with Rheumatoid Arthritis, Tehran, 2010-2011
Public title
The Effect of Oral Contraceptive Pills on Disease Activity in Women with Rheumatoid Arthritis, Tehran, 2010-2011
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : healthy women without any other physical or mental diseases ; oral contraception contraindications; no changes in patient's medication regimen during last three monts; no decision for pregnancy; suspicion of pregnancy; giving medical treatment,no use OCPs during last 6 months
- Exclusion criteria of the study are: Complications detection such as severe nausea and vomiting; because of pills; high risk patients for OCPs
Age
From 18 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Nursing & Midwifery Faculty of Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Touhid Sq
City
Tehran
Postal code
4798/19395
Approval date
0655-12-31, 35/01/-78
Ethics committee reference number
1744411
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Rheumatoid Arthritis disease activity
Timepoint
Befor and 2 months after study
Method of measurement
Instrument DAS-28
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention: Low dose oral Contraceptives Pills administration as routine for 2 cycles in order to contraceptive purpose
Category
Prevention
2
Description
Control: Without any intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Centers
Full name of responsible person
Mehri Kalhor
Street address
Faculty of Nursing and Midwifery of Tehran, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Vice chancellor for research Tehran University of Medical Sciences, Keshavarz Building, Keshavarz Blv, Tehran
City
Tehran
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 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
Faculty of Nursing and Midwifery Tehran
Full name of responsible person
Leila Amini
Position
Master Of Science in Midwifery- Educational Board
Other areas of specialty/work
Street address
Touhid Square, Nursing&Midwifery Faculty
City
Tehran
Postal code
Phone
+98 21 6105 4225
Fax
Email
l-amini@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Master of Science in Midwifery
Other areas of specialty/work
Street address
Nursing&Midwifery School, East Nosrat, Touhid Square
City
Tehran
Postal code
Phone
+98 21 6109 4225
Fax
Email
l-amini@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Iran
Full name of responsible person
Mehri Kalhor
Position
Master of Science in Midwifery
Other areas of specialty/work
Street address
Nursing&Midwifery Shool, East Nosrat, Touhid Square
City
Tehran
Postal code
Phone
00282161054225
Fax
Email
m_kalhor20@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)