Comparison of the therapeutic effect of tranexamic acid with cryotherapy in the treatment of symptoms of cervical ectropion in patients referred to the gynecology clinic of Ayatollah Mousavi Hospital in Zanjan during 2022 and 2023: a randomized clinical trial study
Determining the therapeutic effects of tranxamic acid in comparison with cryotherapy in patients with symptoms caused by cervical ectropion
Design
This clinical trial with parallel groups, single blind, randomized, phase 3 will be performed on 88 patients. A random number table will be used for randomization. Patients with cervical erosion who meet the inclusion criteria will be randomly divided into two groups: tranexamic acid and cryotherapy.
Settings and conduct
This study will be performed as a randomized clinical trial during 2022 and 2023 on patients with cervical ectropion referred to the gynecology clinic of Ayatollah Mousavi Hospital in Zanjan. The study will be single blind, and the data analyst and the person writing the draft will be unaware of the intervention.
In the study group participants, 500 mg of tranexamic acid in the form of a vaginal tablet will be placed in the cervical region with an applicator. Patients are asked to visit on a weekly basis in the first month and then monthly for up to three months. In the control group, cryotherapy will be performed. Patients are asked to visit in the first week after menstrual period. Cryotherapy will be performed using liquid nitrogen / carbon dioxide at zero temperature. Patients will be placed in a lithotomy position.
Participants/Inclusion and exclusion criteria
Non-pregnant women with symptoms of cervical ectropion, including mucoprolant secretions, postpartum hemorrhage, and pelvic pain, who have not responded to routine antibiotic therapy and are between 18 and 45 years old, will be included in the study. Exclusion criteria include: pregnancy, menopause, contraceptive use, IUD, history of known malignancies.
Intervention groups
Administration of 500 mg tranexamic acid daily as a vaginal tablet for ten days
Main outcome variables
Pelvic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220115053719N1
Registration date:2022-02-07, 1400/11/18
Registration timing:prospective
Last update:2022-02-07, 1400/11/18
Update count:0
Registration date
2022-02-07, 1400/11/18
Registrant information
Name
Farzaneh Hekmatfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3332 4059
Email address
hekmatfar.farzaneh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-20, 1400/12/29
Expected recruitment end date
2022-08-27, 1401/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of tranexamic acid with cryotherapy in the treatment of symptoms of cervical ectropion in patients referred to the gynecology clinic of Ayatollah Mousavi Hospital in Zanjan during 2022 and 2023: a randomized clinical trial study
Public title
Tranxamic acid in cervical ectropion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed with cervical ectropion by an experienced gynecologist.
Exclusion criteria:
Pregnancy
Having any known malignancy
Patients in the Menopause period
Intrauterine device (IUD)
Taking contraceptives in the recent 3 months
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use Random number table. We will use concealment allocation, so the assigned group will be unknown. Using opaque, sealed envelopes will be assigned in a random sequence. Finally, the envelopes will be opened respectively and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collectors, outcome assessors, and with lessor importance Data Safety and Monitoring Board and manuscript writers will be blinded about interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Jomhori blvd., Azadi Sq.
City
Zanjan
Province
Zanjan
Postal code
9357118613
Approval date
2022-01-12, 1400/10/22
Ethics committee reference number
IR.ZUMS.REC.1400.428
Health conditions studied
1
Description of health condition studied
Cervical ectropion
ICD-10 code
N86
ICD-10 code description
Erosion and ectropion of cervix uteri
Primary outcomes
1
Description
Pelvic pain
Timepoint
Patients' pain will be evaluated at intervals of zero, the seventh day, the fourteenth day, the twenty-first day, the twenty-eighth day, the sixtieth day and the ninetieth day.
Method of measurement
Visual Analogue Scale will be used to determine the pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 mg Tranexamic Acid vaginal tablet daily for 10 days
Category
Treatment - Drugs
2
Description
Control group: cryotherapy, The cryotherapy probe will be selected based on the size and location of the erosion. Cryotherapy will be performed using liquid nitrogen / carbon dioxide at zero temperature. Patients will be placed in a lithotomy position, cryotherapy will be performed by the gynecologist in charge of the project. The probe will be placed for 3 to 5 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Farzaneh HekmatFar
Street address
Ayatollah Mousavi Hospital. Gavazang Road. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1234567
Phone
+98 915 119 6198
Email
Hekmatfar.farzaneh@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Faramarz Dobakhti
Street address
Jomhori blvd., Azadi Sq.
City
Zanjan
Province
Zanjan
Postal code
12345678
Phone
+98 24 3315 6141
Email
fdobakhti@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Farzane Hekmatfar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi hospital. Gavazang Road. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1234567
Phone
+98 915 119 6198
Email
Hekmatfar.farzaneh@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farzane HekmatFar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi hospital. Gavazang Road. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1234567
Phone
+98 915 119 6198
Email
Hekmatfar.farzaneh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farzane HekmatFar
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ayatollah Mousavi hospital. Gavazang Road. Zanjan
City
Zanjan
Province
Zanjan
Postal code
1234567
Phone
+98 915 119 6198
Email
Hekmatfar.farzaneh@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
the primary outcome measure would be shared .
When the data will become available and for how long
from 2024
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Raw data is not available to individuals and upon request, the results of the requested statistical analysis will be available to individuals.
From where data/document is obtainable
Contact the research expert of the Infertility Clinic of Zanjan University to receive the required documents or data.
What processes are involved for a request to access data/document
To submit a request, it is enough to contact the mentioned expert and send a written and signed request to her.