The comparison of Pap smear quality between the method of Anatomical spatula and common method (spatula-cytobrush) in women referred to gynecology clinics
Objectives: The aim of this study was to evaluate the quality of sampling with Anatomical spatula compared with spatula-cyto brush. Patients included 200 women who were married and referred to gynecology clinic. Inclusion criteria: married, not pregnant, not using vaginal cream. Exclusion criteria: Severe cervicitis, severe genital infection, cuitus in two days before sampling. Intervention: after the interview and filling out the form of Pap smear, first sampling was done with spatula-cytobrush and then anatomical spatula. All slides encoded by two pathologists assigned. Primary outcome: quality of sampling with two different spatulas.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009121548N11
Registration date:2011-01-16, 1389/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-16, 1389/10/26
Registrant information
Name
Khadijeh Abdali
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4255
Email address
abdalikh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2010-01-10, 1388/10/20
Expected recruitment end date
2010-05-02, 1389/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Pap smear quality between the method of Anatomical spatula and common method (spatula-cytobrush) in women referred to gynecology clinics
Public title
The comparison of Pap smear quality with two different methods
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: married, not pregnant, not using vaginal cream. Exclusion criteria: Severe cervicitis, severe genital infection, cuitus in two days before sampling.
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for resaerch, Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2009-09-13, 1388/06/22
Ethics committee reference number
88/4702
Health conditions studied
1
Description of health condition studied
Pap smear
ICD-10 code
Z00
ICD-10 code description
General examination and investigation of persons without complaint and reported diagnosis
Primary outcomes
1
Description
the present of adequacy of cells and endocervical cells
Timepoint
after sameling
Method of measurement
two pathologist report
Secondary outcomes
1
Description
Distribution of cellular infection and inflammations
Timepoint
after sampeling
Method of measurement
two pathologists report
Intervention groups
1
Description
Pap smear with Anatomical spatula
Category
Prevention
2
Description
Pap smear with spatula-cytobrush
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeinabieh hospitul and gyneocology clinics of Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Street address
Fateme Zahra nursing and midwifery faculty, Namazi squer
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Dabbaghmanesh
Street address
Namazi squer
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Vijinda Komar
Position
Professor
Other areas of specialty/work
Street address
Pathology dep. medical faculty, Zand street
City
Shiraz
Postal code
Phone
+98 71 1230 5886
Fax
Email
komar@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Khadijeh Abdali
Position
Master degree of midwifery
Other areas of specialty/work
Street address
Fateme Zahra nursing and midwifery faculty, Namazi squer, Zand street
City
Shiraz
Postal code
Phone
Fax
Email
abdalikh@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)