The aim of this trial is to determine the effect of supplementation during the 7 day with no pill on continuation rate and harassment rate of side effects in new combined pill users. Women who want to start using combined oral contraceptive pills as contraception will be assessed for eligibility criteria. 330 eligible women who give written informed consent will complete a self-administered questionnaire including socio-demographic and reproductive characteristics questions. Then, the subjects will randomly be allocated into three groups using permuted block randomization with block sizes of 3 and 6 (determined by a computerized random number). For 6 cycles, every 28 days subjects in the first group will take 21 LD pills (each pill contains 30 µg ethinyl estradiol and 150 µg levenorgesterol) and 7 multivitamins pills, the second group 21 LD and 7 Placebo pills and the third group 21 LD pills and no pill in the following 7 days. Sequentially numbered opaque sealed envelopes will be used for the allocation concealment which will be opened sequentially after completing the baseline questionnaire by each recruited person. For six months or until discontinuation of the pills, all three group subjects will fill in a questionnaire including some questions about using the pills, harassment rate of side effects and satisfaction from the pills during the cycle when they come to get the next blister of pills in every cycle visit. ANOVA and Cox regression will be used for the data analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210093706N15
Registration date:2012-12-09, 1391/09/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation on the combined pill continuation rate and Harassment rate of its side effects: a randomized controlled trial
Public title
The effect of supplementation on the combined pill continuation rate and Harassment rate of its side effects
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: married no pregnant women aged 18-40 years; intention to start using Low dose (LD) combined pills as a contraceptive method; being literate; not taking combined hormonal methods at least in the past three months.
Exclusion criteria: plan to get pregnant in 6 months; not having medical eligibility criteria for contraceptive use.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
330
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The investigators, participants, and evaluators will be blinded to assignment into the two groups (the groups taking the pills + multivitamins or taking the pills + placebo) but blinding to the third group taking only the pills (7 day with no pill) is not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences, Reaserch deputy
Street address
Golgasht
City
Tabriz
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
91146
Health conditions studied
1
Description of health condition studied
continuation rate of oral contraceptives
ICD-10 code
Y42.4
ICD-10 code description
oral contraceptives
Primary outcomes
1
Description
Continuation rate
Timepoint
monthly
Method of measurement
interview
2
Description
Harrasement rate of side effects of the pills
Timepoint
daily
Method of measurement
interview
Secondary outcomes
1
Description
Correct use of the pills
Timepoint
monthly
Method of measurement
interview
Intervention groups
1
Description
taking 7 multivitamins pills monthly during the 7 day no pill period for 6 months (each pill contains Vitamin A 5000 I.U. , Vitamin B1 1.5 mg , Vitamin B2 1.7 mg , Vitamin B6 2 mg , VitaminC 60 mg , VitaminD3 400 I.U. , Vitamin E 15 I.U. , Vitamin B12 6 mg , Nicotinamid 20 mg and Folic Acid 400 mg )
Category
Prevention
2
Description
taking 7 placebo pills monthly during the 7 day no pill period for 6 months
Category
Prevention
3
Description
No intervention (no pill taking on the 7 days interval between taking every cycle pills)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahid-Madani Health Center
Full name of responsible person
Laya Foroghy
Street address
Shamse Tabrizi Street
City
Marand
2
Recruitment center
Name of recruitment center
Alzahra Health Center
Full name of responsible person
Laya Foroghy
Street address
Ohani Street
City
Marand
3
Recruitment center
Name of recruitment center
Mahbobeh-Sadeghi Health Center
Full name of responsible person
Laya Foroghy
Street address
Abyari square
City
Marand
4
Recruitment center
Name of recruitment center
Shadid-Motahary Health Center
Full name of responsible person
Laya Foroghy
Street address
Jolfa Street
City
Marand
5
Recruitment center
Name of recruitment center
Shahid-Kalantary Health Post
Full name of responsible person
Laya Foroghy
Street address
Yaldor Street
City
Marand
6
Recruitment center
Name of recruitment center
Shahid- kasaei Health post
Full name of responsible person
Laya Foroghy
Street address
Shahid kasaei Street
City
Marand
7
Recruitment center
Name of recruitment center
Shahid-Afrazmand Health Post
Full name of responsible person
Laya Foroghy
Street address
Yaldor Street
City
Marand
8
Recruitment center
Name of recruitment center
Shahid- Beheshti Health Post
Full name of responsible person
Laya Foroghy
Street address
Emam Khomeini Street
City
Marand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Kazem Shakouri
Street address
Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Laiya Forougi
Position
MSc student in midwifery
Other areas of specialty/work
Street address
South Shariatie
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and midwifery, Tabriz university of medical sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in reproductive health
Other areas of specialty/work
Street address
South Shariatie
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Mi8dwifery, Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
PhD in reproductive health
Other areas of specialty/work
Street address
Shariatie Ave.
City
Tabriz
Postal code
Phone
+98 41 1479 7713
Fax
Email
alizades@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)