To improve the clinical symptoms of patients with cervical ectropion and improve their quality of life
Design
A double-blind randomized clinical trial, phase three, in patients with cervical ectropion will be conducted with two groups of 26 people. A table of random numbers was used for randomization.
Settings and conduct
The study will be conducted in patients with cervical ectropion referred to Ayatollah Mousavi clinic in Zanjan in a double-blind manner and in two groups. The clinical caregiver, the patient and the statistician are not aware of the information of the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 45 years old; Complaining of symptoms caused by cervical ectropion, including mucopurulent secretions, postcoital bleeding, and pelvic pain.
Exclusion criteria: Menopause; Being pregnant or becoming pregnant; Taking contraceptives; The presence of an IUD in the uterus; Known malignancy; Unwillingness to participate in the study; Abnormal pap smear result; Pelvic inflammatory disease; HIV infection; Any internal or external genital cancer.
Intervention groups
Patients will be examined in two groups:
1- White alum intervention group (26 people).
2- Intervention group of tranexamic acid (26 people).
Effectiveness of Alum( Potassium Aluminum Sulfate) and Tranexamic acid for Clinical sign and symptoms in patients with ectropion of Cervix
Public title
Effectiveness of Alum( Potassium Aluminum Sulfate) and Tranexamic acid for Clinical sign and symptoms in patients with ectropion of Cervix
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 45 years
Complaining of symptoms caused by cervical ectropion, including mucopurulent secretions, postcoital bleeding, and pelvic pain
Exclusion criteria:
Menopause
Being pregnant or becoming pregnant
Taking contraceptives
The presence of an IUD in the uterus
Known malignancy
Unwillingness to participate in the study
Abnormal pap smear result
Pelvic inflammatory disease
HIV infection
Any internal or external genital cancer
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Allocation will be performed via block randomization. The patients will be included in two groups (blocks) and the drugs will be randomly selected from separate packages that do not present any information about the type of drug by an interventionist who is unaware of the contents of the packages used for the patients.
Randomization Unit: Individuals
Randomization tool: Randomization table
Concealment: The packages of medicines (in the form of pills) contain two packages of pills with the same appearance and color, which differ only in the color of the packages, and the medicines have the same appearance.
Blinding (investigator's opinion)
Double blinded
Blinding description
During the study, the patient will not be informed of the group assigned to her. Also, the interventionist is not aware of the details of the medicine inside the packages and will not know about the patient's group. Finally, the person who will analyze the study data will not know which study group the samples belong to (by coding the patient group).
Placebo
Not used
Assignment
Parallel
Other design features
No similar studies have been done to compare these two drugs in Iran or worldwide; however, there are separate studies related to white alum or tranexamic acid.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, across Asia Insurance, Azadi Blvd.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.ZUMS.REC.1403.048
Health conditions studied
1
Description of health condition studied
Ectropion of cervix uteri
ICD-10 code
N86
ICD-10 code description
Erosion and ectropion of cervix uteri
Primary outcomes
1
Description
The percentage of participants with spoting
Timepoint
Before the start of the intervention, immediately after the start of the intervention, and then the first week
Method of measurement
Medical History
2
Description
The percentage of participants with dyspareunia
Timepoint
Before the start of the intervention, immediately after the start of the intervention, and then the first week
Method of measurement
Medical History
3
Description
The percentage of participants with postcoital bleeding
Timepoint
Before the start of the intervention, immediately after the start of the intervention, and then the first week
Method of measurement
Medical History
4
Description
The percentage of participants with vaginal discharge
Timepoint
Before the start of the intervention, immediately after the start of the intervention, and then the first week
Method of measurement
physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: the use of a single dose of 500 mg vaginal tablet of tranexamic acid by a clinical caregiver using an applicator and maintaining the lithotomy position for 15 minutes in order to prevent displacement.
Category
Treatment - Drugs
2
Description
Intervention group: the use of a single dose of 100 mg white alum vaginal tablet with an applicator by a clinical caregiver and maintaining the lithotomy position for 15 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Zanjan Clinic
Full name of responsible person
Dr Shabnam Towfighi
Street address
Prof Sabooti Avenue
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
dr.razir.rezaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology of Zanjan University of Medical Sciences
Full name of responsible person
Dr. Habib Zeyghami
Street address
Vice-Chancellor for Research and Technology, first floor, second building, Zanjan University of Medical Sciences headquarter, Prof Sabooti Avenue, Zanjan city