Objective: Cervical cancer is one of the most frequent female cancers which is usually diagnosed late. Papanicolaou test is an important screening tool for its early diagnosis, but it has too many false-negative results. We evaluated in this study the effect of cervical discharge cleaning with a big cotton swab before taking the smear on increase diagnostic efficacy of this test. Materials and methods: This study is a randomized clinical trial which was conducted from September 2007 until December 2010 in 500 women who came to Tehran Bouali Hospital gynecology clinic and had indication for papanicolaou test. These women were divided into two groups as case and control by random allocation. In case group before taking the smear, cervical discharge was cleaned by a big cotton swab. In control group the smear was taken in traditional way with spatula. At last the quantity (presence of 8000-12000 squamous cells), quality (presence or absence of endocervical cells) and amount of inflammatory exudates in the smears (high: coverage of >75% of smear, moderate: coverage of 50-75% of smear, low: coverage of <50% of smear with inflammatory exudate) were compared in two groups using Mann-witney, χ2, Fisher-exact test and t-student test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112318560N1
Registration date:2012-04-08, 1391/01/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-08, 1391/01/20
Registrant information
Name
Gita Hatamizadeh
Name of organization / entity
Tehran Medical Branch of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 2231 1587
Email address
ghatamizadeh@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2010-12-20, 1389/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cervical cleaning with a big cotton swab on pap smear samples quality
Public title
The effect of cervical cleaning with a big cotton swab on pap smear samples quality
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria: all women with history of coitus; women who had not pap smear from one year ago. Exclusion criteria: acute vaginitis or cervicitis; vaginal bleeding; a history of total hysterectomy; menopause women; pregnant women.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
500
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
Tehran medical branch of Islamic Azad university
Street address
Zargandeh st., Shariati Ave.
City
Tehran
Postal code
1495/19395
Approval date
2006-12-04, 1385/09/13
Ethics committee reference number
4396
Health conditions studied
1
Description of health condition studied
cervical carcinoma
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
quantity (presence of 8000-12000 squamous cells)
Timepoint
sampling is done at the same time when cervix is cleaned
Method of measurement
Bethesda criteria
2
Description
quality (presence or absence of endocervical cells)
Timepoint
sampling is done at the same time when cervix is cleaned
Method of measurement
Bethesda criteria
3
Description
amount of inflammatory exudates in the smears (high: coverage of >75% of smear, moderate: coverage of 50-75% of smear, low: coverage of <50% of smear with inflammatory exudate)
Timepoint
sampling is done at the same time when cervix is cleaned
Method of measurement
Bethesda criteria
Secondary outcomes
empty
Intervention groups
1
Description
cleaning of cervical discharge by a big cotton swab before taking sample for pap smear
Category
Early detection
2
Description
no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital gynecology clinic
Full name of responsible person
Dr. Gita Hatamizadeh
Street address
Emam Hosein square, Damavand ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gita Hatamizadeh
Full name of responsible person
Gita Hatamizadeh
Street address
Emam Hosein square- Damavand ave.
City
Tehran
Grant name
بودجه توسط محقق فراهم شده است
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gita Hatamizadeh
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran medical branch of Islamic Azad university
Full name of responsible person
Gita Hatamizadeh
Street address
Zargandeh street, Shariati ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?