Main outcomes:
Using the best device for Pap smear
Design:
This study designed as a randomized clinical trial study, not blinded, crossover.
Setting and conduct:
All married women between 21-65 years old who have indication for pap smear included in study and in first time will be collected sample for pap smear with one of cervix brush or cytobrush-spatula and 30 days later test will repeated with the other device then samples will be send for reporting to a pathologist who has not any information about patients and Pap smear devices. Then results analyzed and described by BETHESDA system.
Participants inclusion and exclusion criteria:
In both time patient with clinical infection or PID or vaginal discharge or intercourse for 48 h ago or administer vaginal agent or pregnant person will be deleted as person that in first result of Pap smear have infection.
Intervention:
Dose not has.
Objectives measures variables:
pap smear
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111811504N1
Registration date:2013-08-11, 1392/05/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-08-11, 1392/05/20
Registrant information
Name
Sanam Moradan
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1446 0066
Email address
smoradan@sem.ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Semnan University of Medical Science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pap smear quality with spatula-cytobrush versus cervix brush methods in women 21-65 years old
Public title
Comparison of Pap smear quality with spatula-cytobrush versus cervix brush methods
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: married women between 21-61 years old who have indication for pap smear.
Exclusion criteria: Clinical infection or PID; vaginal bleeding ; intercourse in 48 h ago; use of vaginal agent; pregnancy; person who had infection in first pap smear; person who dosent come for second time.
Age
From 21 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Semnan University of Medical Sicense
Street address
Central Department, Semnan University of Medical Sicense, Basidj Bulvard
City
Semnan
Postal code
Approval date
2012-11-13, 1391/08/23
Ethics committee reference number
91/16/10616
Health conditions studied
1
Description of health condition studied
Comparison of Pap smear quality in two methods
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
adequacy of cell
Timepoint
1 mounts after intervention
Method of measurement
result of the papsmear
Secondary outcomes
1
Description
sub clinical infection
Timepoint
1 mount after intervention
Method of measurement
result of the papsmear
Intervention groups
1
Description
All patients who have enclosion criteria undergo pop smear and in first time with one of cervix brush or cytobrush_spatula then samples send to laboratory and blindly describe them with BETHESDA
Category
Diagnosis
2
Description
30 days after first examination the test repeated with the other device and samples send to laboratory for description.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Sanam Moradan
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Science
Full name of responsible person
Raheb Ghorbani
Street address
Central Department of Semnan University of Medical Science, Basidj Bulvard
City
Semnan
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 of Semnan University of Medical Science
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
Semnan University of Medical Science
Full name of responsible person
Dr. Sanam Moradan
Position
Gynecologist/ Associte professor
Other areas of specialty/work
Street address
Amir Al Momenin Hospital، Imam Hussein square
City
Semnan
Postal code
Phone
+98 23 1444 1420
Fax
Email
sm42595@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr. Sanam Moradan
Position
Gynecologist
Other areas of specialty/work
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan
Postal code
Phone
+98 23 1444 1420
Fax
Email
sm42595@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Moloud Moghadas
Position
Medical Student
Other areas of specialty/work
Street address
Amir Al Momenin Hospital, Imam Hussein Square
City
Semnan
Postal code
Phone
00
Fax
Email
moghadas_moloud@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)