The aim of this study is comparison of Pap smear adequacy by two instrument ayre spatula and cervix brush in patient who referred to a private clinic. This study is a clinical trial 400 patient who needs to perform Pap smear randomized in two groups with block randomized half by ayre spatula and half by cervix brush. Inclusion criteria include all patients who need to perform Pap smear. Exclusion criteria include: pregnant women, women who is on HRT and the patients with cervicitis. The specimen were evaluated (by one pathologist) based on Bethesda classification. The primary result was existence or obscene of endocervical cell and classified into two groups. Adequate or inadequate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206131306N4
Registration date:2012-07-10, 1391/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-10, 1391/04/20
Registrant information
Name
Ziba Zahiri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
drzibazahiri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research – Guilan university of medical sciences
Expected recruitment start date
2007-07-09, 1386/04/18
Expected recruitment end date
2009-08-17, 1388/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Papsmear adequacy with either Ayrespatula and Cervix brush in patients reffered to a private medical office,2007-2008
Public title
Comparison of Papsmear adequacy with either Ayrespatula and Cervix brush
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criterion: all patients who need to perform Pap smear.
Exclusion criteria: pregnant women who are under HRT and the patients with cervicitis.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
medical school, Guilan university of Medical sciences
Street address
Tehran street
City
Rasht
Postal code
Approval date
2007-07-09, 1386/04/18
Ethics committee reference number
1233
Health conditions studied
1
Description of health condition studied
Comparison of Papsmear adequacy with either Ayrespatula and Cervix brush
ICD-10 code
U00-U49
ICD-10 code description
Provisional assignment of new diseases of uncertain etiology
Primary outcomes
1
Description
Adeaquacy of pap smear in Ayre spatula and Cervix brush
Timepoint
Between menstrual cycle
Method of measurement
with Ayre spatula and Cervix brush
Secondary outcomes
1
Description
Adeaquacy of pap smear in Ayre spatula and Cervix brush by parity
Timepoint
Between menstrual cycle
Method of measurement
with Ayre spatula and Cervix brush
2
Description
Adeaquacy of pap smear in Ayre spatula and Cervix brush by Menopause
Timepoint
one year after Lack of menstruation
Method of measurement
with Ayre spatula and Cervix brush
3
Description
adequacy of Causes of non-satisfactory in Ayre spatula and Cervix brush
Timepoint
Between menstrual cycle
Method of measurement
Based on presence or absence of an adequate endocervical cells
Intervention groups
1
Description
use Ayre spatula in first group
Category
Diagnosis
2
Description
use Cervix Brush in second group
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Private practice
Full name of responsible person
Dr Ziba Zahiri
Street address
Reproductive health research Center, Al_Zahra Hospital, Namjoo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research – Guilan university of medical sciences
Full name of responsible person
Dr Abdol Rasol Sobhani
Street address
Guilan University Of Medical Sciences
City
Rasht
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 – Guilan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Ziba Zahiri
Position
Associated professor Gilan University of Medical Science
Other areas of specialty/work
Street address
Reproductive Health Research Center, Al_Zahra Hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
drzibazahiri@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
seyedeh maryam mosavi chahardeh
Position
B.S. midwife
Other areas of specialty/work
Street address
Reproductive Health Research Center,Al_Zahra Hospital, Namjoo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
maryammosavi1363@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)