A Comparison of the Effect of two suture materials on Isthmocele formation after cesarean
Design
150 pregnant women who meet the inclusion criteria by random block method will be divided into two groups using chrome and vicryl yarn. Using the balanced block randomization method, we form 6 blocks of 4 from B and A. Then, based on the table of random numbers, we assign 1 to 6 to the blocks, and in the second step, we put the blocks together based on the coincidence. In this way, there will be an equal number of two groups in each block and we will continue the sampling process until we reach the desired sample size. Data analysis will be done using SPSS statistical software version 24
Settings and conduct
150 pregnant women with eligibility criteria who undergo cesarean delivery in Kowsar Medical Center (affiliated to Qazvin University of Medical Sciences) since 2022 after obtaining written consent to cooperate are randomly selected. To reduce bias, single-blind method is used in such a way that the sonographer does not know the type of thread used in cesarean section.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age over 18 years 2- Single pregnancy 3- Gestational age over 38 weeks 4- First cesarean section
Exclusion indications: 1- Multifetal pregnancy 2- History of previous cesarean section 3- History of uterine surgery such as myomectomy 4- Cesarean section in active labor phase (dilation above 4 cm) 5- Diabetes 6- Chronic hypertension 7- Preeclampsia 8- Anemia (Hb <10/5)
Intervention groups
Patients will be randomly divided into two groups using chrome and vicryl yarn.
Main outcome variables
Isthmocell formation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220507054766N1
Registration date:2022-08-08, 1401/05/17
Registration timing:registered_while_recruiting
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
samane nasiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3378 6861
Email address
snasiri550@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-08, 1401/02/18
Expected recruitment end date
2023-03-09, 1401/12/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effect of two Suture Materials on Isthmocele Formation after Cesarean section
Public title
A Comparison of the Effect of two Suture Materials on Isthmocele Formation after Cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Single tone pregnancy
Gestational age over 38 weeks
First cesarean section
Exclusion criteria:
History of uterine surgery such as myomectomy
Cesarean section in the active phase of labor (dilation above 4 cm)
Diabetes
Chronic blood pressure
Preeclampsia
Anemia (Hb <10/5)
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be divided into two groups by balanced blocked randomization. Blocking and sequencing of samples will be done with random allocation software (Random Allocation Software 1.0) and will include 25 blocks of 6. In order to conceal the random allocation process, the names of the groups were placed in envelopes, numbered from 1 to 150 on these envelopes and arranged in a box, the contents of the envelopes indicated the study groups. And after ensuring that the sample enters the research and obtaining written consent, the first envelope is taken in order of number and according to the content of the envelope, they are placed in one of the study groups
Blinding (investigator's opinion)
Single blinded
Blinding description
The sonologist does not know the type of suture used to close the uterine incision.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
No 33, 7 Erfan, komil ave
City
qazvin
Province
Qazvin
Postal code
3471956654
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.QUMS.REC.1401.018
Health conditions studied
1
Description of health condition studied
A comparison of the effect of two suture materials on isthmocele formation after cesarean
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Isthmocell formation
Timepoint
Examination of isthmocell formation 3 months after cesarean section
Method of measurement
Using ultrasound
Secondary outcomes
1
Description
Duration of operation,
Timepoint
Time recorded in the file
Method of measurement
Based on the information in the patient file
2
Description
amount of bleeding during surgery
Timepoint
6 hours after surgery
Method of measurement
Primary hemoglobin minus hemoglobin 6 hours after surgery
3
Description
Spotting
Timepoint
3 months after surgery
Method of measurement
Question from the patient
Intervention groups
1
Description
Use of chrome thread to repair hysterotomy in cesarean section/ Chromic CAT GUT surgical sutures of Kayhan Teb Company are taken from cleaned connective tissue (collagen) and are prepared from sheep intestines. These yarns are packed in a solution of 90% alcohol, 2% glycerin and 8% distilled water. Chromic CAT GUT suture is impregnated with a solution of chromic salts.
Category
Treatment - Devices
2
Description
Use of vicryl suture to repair hysterotomy in cesarean section /PGA is a sterile absorbable synthetic suture (vicryl) suture from Tamin Salamat Company, which is composed of polyglycolic acid polymer. The multi-strand woven yarn is coated with a mixture of calcium stearate and polycaprolactone to reduce yarn friction with the fabric. PGA suture is available in purple and colorless form (white). PGA suture meets the requirements of European and American pharmacopoeia.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Samane Nasiri
Street address
Valiasr Street
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3324 2661
Email
itkosar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samane nasiri
Street address
Valiasr Street
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3324 2661
Email
itkosar@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Samane nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 33, Kamil Erfan St
City
Qazvin
Province
Qazvin
Postal code
3471956654
Phone
+98 28 3378 6861
Email
snasiri550@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farideh Movahed
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr Street
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3324 2661
Email
drmovahed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samane nasiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 33, Kamil Erfan St.
City
Qazvin
Province
Qazvin
Postal code
3471956654
Phone
+98 28 3378 6861
Email
snasiri550@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
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
All data of this research will be available
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
It will be accessible to everyone
Under which criteria data/document could be used
-
From where data/document is obtainable
website
What processes are involved for a request to access data/document