The aim of the study was to evaluate the efficacy of HPV vaccine in preventing of increasing cervical lesion in abnormal Pap test.
Design
This is a double-blind randomized controlled trial.
Settings and conduct
Between 2011-2015, 242 women between the ages of 22 to 50 years that suffering from various degrees of cervical lesions ( CIN1, 2, 3) and referred to women’s clinic affiliated to Shahid Sadoughi Hospital, Yazd, Iran, by signing a consent were studied to evaluate the effectiveness of HPV vaccine. Throughout the 2 years, all patients were treated according to the protocol; in addition, the results of the cervix inspections were documented. The collected data were analyzed using SPSS, chi-square, and fissure exact tests.
Participants/Inclusion and exclusion criteria
In this study, 242 women that had various grades of infection (CIN1, 2, 3) which referred to a women’s clinic affiliated to Shahid Sadoughi University of Medical Sciences and Health Services for determining the effectiveness of HPV vaccine, by signing a consent were studied.
Intervention groups
In the intervention group, 138 women received HPV vaccinations. Throughout the 2 years, all patients were treated according to the protocol;
Main outcome variables
The main result of this study was to prevent increasing cervical lesion in an abnormal Pap test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190603043801N1
Registration date:2019-07-24, 1398/05/02
Registration timing:retrospective
Last update:2019-07-24, 1398/05/02
Update count:0
Registration date
2019-07-24, 1398/05/02
Registrant information
Name
mojgan Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2680
Email address
drkarimi2001@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
2011-10-01, 1390/07/09
Actual recruitment end date
2015-11-01, 1394/08/10
Trial completion date
2015-11-01, 1394/08/10
Scientific title
Efficacy of HPV vaccine in preventing of increasing cervical lesion in abnormal Pap test
Public title
Efficacy of HPV vaccine in preventing of increasing cervical lesion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women suffering from various degrees of cervical lesions ( CIN 1, 2, 3)
Exclusion criteria:
Pregnant women
Women with severe allergies
Age
From 22 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
242
Actual sample size reached:
242
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized blocking method of four blocking was used using R statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blinded study that investigator and outcome assessor were completely blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
by Ethics Committee of the Yazd Shahid Sadoughi University of Medical Sciences
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
IR. IAU. YAZD. REC. 1394.008
Health conditions studied
1
Description of health condition studied
Cervical cancer
ICD-10 code
C51-C58
ICD-10 code description
Cervical cancer
Primary outcomes
1
Description
Clinical finding
Timepoint
At 1, 7, 12, 18, 24 months
Method of measurement
Gynecological examination
2
Description
Pap tests results
Timepoint
At 1, 7, 12, 24 months
Method of measurement
Pap smear Testing
Secondary outcomes
empty
Intervention groups
1
Description
In the Intervention group, women received three dosages of HPV vaccination.
Category
Treatment - Drugs
2
Description
In control group, women did not receive any dosages of HPV vaccination.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinic affiliated to Yazd University of Medical Sciences
Full name of responsible person
Mojgan Karimi Zarchi
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Email
drkarimi2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research and Technology
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mojgan Karimi -Zarchi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 21 6435 2680
Email
drkarimi2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mojgan Karimi Zarchi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 21 6435 2680
Email
drkarimi2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mojgan Karimi Zarchi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 21 6435 2680
Email
drkarimi2001@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available