Determining the effectiveness of exosome injection compared to sterile water at the scar site during cesarean section on niche size in women with third cesarean section
Determining the effectiveness of injecting exosomes into cesarean scar in women with third caesarean section
Design
This is a randomized triple-blind ,placebo control, phase 3 clinical trial involving a total of 60 patients. For randomization, 30 "A" labels and 30 "B" labels will be placed inside some envelopes and then in a box. For each patient an envelope is drawn out of the box. The physician, the patients, and the data analyst are be blinded to groups assignments.
Settings and conduct
This triple blinded clinical trial with an intervention group (exosomes injection) and a control group (sterile water injection that is similar regarding appearance and form) will be conducted at the IVF operation room of Yas Hospital of Tehran. Study population: women with a previous caesarean section; Blinding: The patients, physician, and data analysts will be blinded to the groups assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all women who are candidate for second cesarean section; being at the age of 20-40 years.
Exclusion criterion: history of cesarean scar
Intervention groups
Intervention group (exosome): during cesarean after delivering baby, uterine incision will be repaired by vicryl 1 and exosomes injected in the site of scar. Control group (sterile water): during cesarean after delivering baby, uterine incision will be repaired by vicryl 1 and strile water injected in the site of scar.
Main outcome variables
Niche size based on transvaginal sonogram at 6th week post operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N45
Registration date:2024-08-17, 1403/05/27
Registration timing:prospective
Last update:2024-08-17, 1403/05/27
Update count:0
Registration date
2024-08-17, 1403/05/27
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of exosome injection compared to sterile water at the scar site during cesarean section on niche size in women with third cesarean section
Public title
The effect of exosomes for third cesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women who are candidate for third cesarean section
Age of 20-40 years
Exclusion criteria:
History of cesarean scar
Age
From 18 years old to 44 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: At first, on special unmarked papers, 30 A letters and 30 B letters are written. Then all (60) are placed in a bag and for each patient, after obtaining informed consent, a paper is taken out randomly without replacement. Based on the letter written on it, the intended intervention is performed on the patient. In addition, interventions A (exosome injection) or B (sterile water injection) are determined by lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physician are blinded regarding the groups ( exosomes or sterile water injection ,that are the same regarding appearance and form), and analyzer only sees the codes in data sheet and is blinded regarding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of medical sciences
Street address
Deputy of Research, sixth floor, Central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-08-12, 1403/05/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.203
Health conditions studied
1
Description of health condition studied
Cesarean niche
ICD-10 code
034.2
ICD-10 code description
Maternal care due to uterine scar from previous surgery
Primary outcomes
1
Description
Cesarean scar diametere
Timepoint
Six weeks after surgery
Method of measurement
Measuerment of scar site by transvaginal sonogram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During cesarean after delivering baby ,uterine incision will be repaired by vicryl 1and exosomes injected in the site of scar.
Category
Treatment - Surgery
2
Description
Control group: During cesarean and after delivering baby, uterine incision will be repaired by vicryl 1 and sterile water will be injected in the site of scar.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Deputy of Research, sixth floor of central building of Tehran University of medical sciences, Ghods Avenue, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8161 3000
Email
Tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi Avenue, Karim khan Zand Bridge
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
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
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
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After manuscript published
To whom data/document is available
The data is available to the project manager, Dr.Davari and any analysis must be done with her permission.
Under which criteria data/document could be used
No limitation.
From where data/document is obtainable
Dr.Davari through email, fdavaritanha@sina.tums.ac.ir
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Davari.