Evaluation the efficacy of Amniotic membrane on chronic cervicitis in patients referring to obstetrics and gynecology clinic.
Design
Randomized control open labeled trial of 60 patients based on random numbers table
Settings and conduct
Patients are selected from women referring to the gynecologist's clinic who are candidates for treatment of chronic cervicitis and volunteer to participate in the study and are eligible to enter the study. The basic characteristics of the patients will be extracted using a questionnaire. Women who have chronic cervicitis and underwent colposcopy after 3 months, and as a result of colposcopy, there were no precancerous lesions and were HPV negative, will included in the study and will divided into two equal groups in a ratio of one to one, and randomization will be done using a table of numbers. It happens randomly.For one group, amniotic membrane (amniodisc of Sinacell company) and drug treatment of cervicitis will use, and for the other group, only drug treatment of cervicitis will use. Then, after one month, the patients will be examined again in terms of clinical symptoms (post coital bleeding, vaginal discharge, vaginal itching, and pelvic pain) and colposcopy findings.
Participants/Inclusion and exclusion criteria
1. Married women between 25-45 years old with chronic cervicitis who are not menstruating.
2. Not having any underlying disease such as diabetes, blood pressure, autoimmune diseases
3. Having normal colposcopy results and not having HPV and acute infection
4. Absence of substance abuse
5. Not using OCP and drugs that weaken the immune system (corticosteroid drugs)
6. Not using IUD
Intervention groups
For the intervention group, amniotic membrane (Amniodisc of Sinacell Company) and drug treatment of cervicitis will be used.
Main outcome variables
Clinical and paraclinical symptom of cervicitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220822055772N2
Registration date:2024-10-02, 1403/07/11
Registration timing:prospective
Last update:2024-10-02, 1403/07/11
Update count:0
Registration date
2024-10-02, 1403/07/11
Registrant information
Name
Hanieh Najafiarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7758 2543
Email address
h_najafi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation the efficacy of Amniotic Membrane on treatment of chronic cervicitis: an open labeled randomized control trial
Public title
evaluation the efficacy of Amniotic Membrane on treatment of cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women between 25-45 years old with chronic cervicitis who are not menstruating
Absence of underlying disease such as diabetes, blood pressure, autoimmune diseases
Having normal colposcopy results and not having HPV and acute infection
Absence of substance abuse
Not taking OCP and drugs that weaken the immune system (corticosteroid drugs)
Not using an IUD
Exclusion criteria:
Unwillingness to continue participating in the study
sensitive reaction to amniotic membrane or medical treatment
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE).
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
Ethics committees of School of Medicine - Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-09-08, 1403/06/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.279
Health conditions studied
1
Description of health condition studied
women with cervicitis
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
Primary outcomes
1
Description
Clinical symptom of cervicitis including vaginal discharge, vaginal itching, post coital bleeding, pelvic pain
Timepoint
one month after intervention
Method of measurement
medical history
2
Description
para clinical symptom of cervicitis including colposcopic visualization
Timepoint
one month after intervention
Method of measurement
colposcopy
Secondary outcomes
1
Description
Changing the size of the cervical wound
Timepoint
one month after intervention
Method of measurement
colposcopy
Intervention groups
1
Description
In the intervention group, for the treatment of cervicitis, an amnion membrane (amniodisc of Sinacell company) is used as a one-time placement of the dressing in the affected area and medical treatment of cervicitis includes one gram of azithromycin.
Category
Treatment - Other
2
Description
Control group: medical treatment of cervicitis includes one gram of azithromycin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Hanieh Najafiarab
Street address
Imam Hossein Square, Shahid Madani Street, Tehran Province, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
haniye.najafiarab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Najafiarab
Position
Research Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7758 2543
Email
Haniye.najafiarab@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available