1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of chromium and vicryl yarn on the extent and severity of cesarean scar defects (nich) in patients undergoing cesarean section

Protocol summary

Study aim
Determining the relationship between the type of suture used and the incidence and severity of cesarean scar defects (nich) in patients with a history of cesarean
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, was performed on 50 women who underwent cesarean section, and randomization was performed based on a table of random numbers in two groups of 25 people.
Settings and conduct
The effect of suture type in repairing different sites of the body such as episiotomy repair, subcutaneous layer repair and skin repair has been studied in various studies. Therefore, in this two-way blind study, the effect of suture type on myometrial repair was investigated in such a way that after randomization, two groups of 25 people, one after cesarean section were sutured with chromic suture and the other group was sutured with vicryl suture. At least 2 months after cesarean section, patients were examined for the incidence of cesarean scar defects (Nich) by a 5MHz Mindrey vaginal ultrasound machine.
Participants/Inclusion and exclusion criteria
Inclusion: Women undergoing cesarean section for the first time Exclusion: history of previous cesarean section, diseases such as diabetes, hypertension, preeclampsia, multiple pregnancies
Intervention groups
A total of 50 women underwent cesarean section were included in the study in terms of inclusion and exclusion criteria and were randomly divided into two groups of 25 based on a table of random numbers. The group that underwent stitching with chromic round 1 thread of Shahid Safai company after cesarean section and the other group underwent suture with vicryl round thread 1 of supk company.
Main outcome variables
The use of chrome thread is associated with more cesarean defects. Therefore, the use of vicryl thread instead of chrome is recommended to reduce the incidence of cesarean scar defects.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210423051055N1
Registration date: 2021-05-20, 1400/02/30
Registration timing: retrospective

Last update: 2021-05-20, 1400/02/30
Update count: 0
Registration date
2021-05-20, 1400/02/30
Registrant information
Name
Mina Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 2761
Email address
drminarahmani2@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-04-01, 1400/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chromium and vicryl yarn on the extent and severity of cesarean scar defects (nich) in patients undergoing cesarean section
Public title
The relationship between the type of suture used and the incidence and severity of cesarean scar defects (nich)
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have had a cesarean section for the first time
Exclusion criteria:
History of previous cesarean section Having diabetes, high blood pressure and preeclampsia Multiple pregnancies
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 50 women who underwent cesarean section were included in the study in terms of inclusion and exclusion criteria and were randomly divided into two groups of 25 based on a table of random numbers.In this way, after determining the sample size, which included 50 women undergoing cesarean section, 50 codes were prepared and then a random selection by computer was considered a code for each person and we put the code related to each person in front of their name.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 50 women underwent cesarean section in two groups of 25 people. One group underwent chromium suture after cesarean section and the other group underwent suture with vicryl suture. The study was double-blind and patients and physicians did not know how to group them.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Medical School-Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shahid Sadoughi Hospital, Ibn Sina Blvd.
City
Yazd
Province
Yazd
Postal code
8915814739
Approval date
2020-09-13, 1399/06/23
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.141

Health conditions studied

1

Description of health condition studied
cesarean scar defects (nich) in patients with a history of cesarean
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery

Primary outcomes

1

Description
Age
Timepoint
The beginning of the study
Method of measurement
Number of years of life

2

Description
Type of suture
Timepoint
During a cesarean section
Method of measurement
Type of suture used in cesarean section (chrome / Vicryl )

Secondary outcomes

1

Description
Nich
Timepoint
2 months after cesarean section
Method of measurement
Based on ultrasound findings (yes / no)

2

Description
Cervical dilatation
Timepoint
2 months after cesarean section
Method of measurement
Based on examination and ultrasound findings

Intervention groups

1

Description
Intervention group: After cesarean section, the group underwent sutures with chromic round 1 suture of Shahid Safai Company and after 2 months were examined by Mindrey vaginal ultrasound machine with a frequency of 5 MHz for nich lesions.
Category
Diagnosis

2

Description
Control group: The group that underwent sutures with supa Vicryl Round 1 sutures and after 2 months were examined by Mindrey vaginal ultrasound machine with a frequency of 5 MHz for nich lesions.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Mina Rahmani
Street address
Atlasi 15, Atlasi Street, Safaieh.
City
Yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
h.salmanroghani@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Ibn Sina Boulevard
City
Yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4000
Email
dr_smm2020@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mina Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 3, Day apartment, 14 allay, Atlasi Ave, Yazd Town,
City
Yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3826 2761
Fax
Email
drminarahmani2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Razieh sadat tabatabaei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
University Boulevard next to Vakil Real Estate, Safaieh.
City
yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3822 4443
Email
Dr.r.tabatabaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mina Rahmani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 3, Day apartment, 14 allay, Atlasi Ave, Yazd Town,
City
Yazd
Province
Yazd
Postal code
8915814739
Phone
+98 35 3826 2761
Fax
Email
drminarahmani2@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
Because of moral issues
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Loading...