Determining the effect of amniotic membrane (amniodisc) in treatment of chronic cervical infection in female patients admitted in Besat Hospital in Sanandaj in 2024-2025
Design
The clinical trial has a control and intervention group, randomized open label trial is used to study 44 patients which have been divided completely randomly based on block randomization .
Settings and conduct
This study is conducted in the gynecology clinic of Besat Hospital, Sanandaj . volunteers with chronic cervical infection are included after examination based on the checklist of inclusion and exclusion criteria .Patients in the control group receive standard treatment for chronic cervicitis but for patients in intervention group amniotic membrane is used along with receiving standard treatment for chronic cervicitis . patients will be evaluated after one month .
Participants/Inclusion and exclusion criteria
Married women 18-50 years old
Having vaginal discharge, lower abdominal pain, dysuria, vaginal odor, vaginal itching, dyspareunia, bleeding and pain after coitus.
Women with severe inflammatory pap smear results
Use of treatment for acute cervical infection before starting the study
patients' tendency to participate in the study
Exclusion criteria:
1- Single, pregnant and lactating women
2- People with reduced immune system due to illness or drug use
3-Having multiple sexual partners
4-Having acute cervical infection
5-Patients with cervical malignancies
6-People with mild to moderate inflammatory pap smear results
Intervention groups
In the intervention group, in addition to the standard treatment of cervicitis, the amniotic membrane is also used and visually examined by colposcopy for patients, and just the standard treatment of cervicitis is used for control group .
Main outcome variables
chronic cervical infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241007063283N1
Registration date:2025-01-14, 1403/10/25
Registration timing:registered_while_recruiting
Last update:2025-01-14, 1403/10/25
Update count:0
Registration date
2025-01-14, 1403/10/25
Registrant information
Name
Leila Taherabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3328 2004
Email address
taherabadi81@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of amninotic membrane in the treatment of chronic cervical infection in female patients admitted in Sanandaj Besat hospital
Public title
Study of effect of amninotic membrane in the treatment of chronic cervical infection in female patients admitted in Sanandaj Besat hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women 18-50 years old
Having vaginal discharge, lower abdominal pain, dysuria, vaginal odor, vaginal itching, dyspareunia, bleeding and pain after coitus.
Women with severe inflammatory pap smear results
Use of treatment for acute cervical infection before starting the study
patients' tendency to participate in the study
Exclusion criteria:
Single, pregnant and lactating women
women with reduced immune system due to illness or drug use
Having multiple sexual partners
Having an acute cervical infection
Patients with cervical malignancies
women with mild to moderate inflammatory pap smear results
Age
From 18 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided completely randomly based on block randomization.
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 Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6617715175
Approval date
2024-09-03, 1403/06/13
Ethics committee reference number
IR.MUK.REC.1403.124
Health conditions studied
1
Description of health condition studied
Chronic cervicitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Cervical infection
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Examination by a doctor, Pap smear, and colposcopy image viewing
Secondary outcomes
empty
Intervention groups
1
Description
intervention group : Amniotic membrane is the main intervention in this study . by using inclusion and exclusion criteria and after examination by a doctor Patients are involved . the patients will be undergoing standard cervical treatment along with receiving prepared amniotic membrane patches provided by Sinacell co. for using on the cervix .
Category
Treatment - Other
2
Description
Control group : In this group, patients will be undergoing standard cervical treatment after confirming cervicitis through examination and after entering the study using the inclusion and exclusion criteria.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic, Besat Hospital, Sanandaj
Full name of responsible person
Leila taherabadi
Street address
Keshavarz Ave .
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۹۶۶۷۷۶۱
Phone
+98 87 3328 5911
Email
taherabadi81@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. afshin maleki
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3366 4643
Email
paralib@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Sinacell Manufacturing - Research Company
Full name of responsible person
Maryam mahmudiniya
Street address
Sinacell co. No 162 , Noavari 16th street. Pardis science and technology park Jajrud road
City
Tehran
Province
Tehran
Postal code
1654120596
Phone
+98 21 7625 0661
Email
Info@Sinacellco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sinacell Manufacturing - Research Company
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Leila Taherabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Besat hospital , Keshavarz Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617794719
Phone
+98 87 3328 2004
Fax
Email
taherabadi81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Leila Taherabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Besat hospital , Keshavarz Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617794719
Phone
+98 87 3328 2004
Fax
Email
taherabadi81@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Leila Taherabadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Besat hospital , Keshavarz Ave.
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3328 2004
Fax
Email
taherabadi81@gmail.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
The result of the study is not related to the publication of individual data
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
No - There is not 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