Protocol summary

Study aim
Comparison of the outcome of uterine incision suture with the magon - babo technique (new technique) with the conventional method.
Design
In a randomized clinical trial with the parallel control group, double-blind; Phase 2-3, on 240 patients; randomization is performed by using block randomization
Settings and conduct
In this double-blind clinical trial parallel study, 240 patients who are candidates for cesarean section in Fatemieh Hospital in Hamadan will be included in the study. The researcher who measures and records the consequences and the patients are unaware of the type of intervention performed, so the study is conducted in a double-blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Single pregnancy, Age between 18 and 45 years, Gestational age between 24 and 41 weeks, and history of previous cesarean section Exclusion criteria: Multiple pregnancies, Diabetes, Chronic inflammatory diseases such as lupus, rheumatoid arthritis
Intervention groups
New technique group: After a cesarean section, in patients with chromic suture round 1 of Supa company, the whole layer of the myometrium, the incision site is cut from one centimeter away, and the decidua part is swabbed in both upper and lower parts, and examined for nich lesions. Conventional technique group:The uterus is sutured in two layers, the first layer is lacquered and the second layer is lacquered chrome 1 round without Supa company and are examined for nich lesions
Main outcome variables
Nich, residual myometrial thickness, Spotting, and Pelvic pain 6 & 9 months after cesarean section

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160523028008N24
Registration date: 2022-07-16, 1401/04/25
Registration timing: registered_while_recruiting

Last update: 2022-07-16, 1401/04/25
Update count: 0
Registration date
2022-07-16, 1401/04/25
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome of uterine incision suture with the magon - babo technique (new technique) with the conventional method.
Public title
Comparison of the outcome of new method of uterine incision sutur
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy Age between 18 and 45 years Gestational age between 24 and 41 weeks history of previous cesarean section
Exclusion criteria:
Multiple pregnancies Diabetes Chronic inflammatory diseases such as lupus, rheumatoid arthritis
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention(new method) and on the other two sheets the name of the control( routine method). The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action is repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher who measures and records the consequences and the patients are not aware of the type of intervention performed, so the study is performed in a double-blinding manner.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.148

Health conditions studied

1

Description of health condition studied
Maternal care for scar from previous cesarean delivery
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery

Primary outcomes

1

Description
Nich
Timepoint
6 & 9 months after cesarean section
Method of measurement
Based on ultrasound findings (yes / no)

Secondary outcomes

1

Description
Residual myometrial thickness
Timepoint
6 & 9 months after cesarean section
Method of measurement
Based on ultrasound findings (mm)

2

Description
Pelvic pain
Timepoint
6 & 9 months after cesarean section
Method of measurement
Asking from patient ( Visual Analogue Scale)

Intervention groups

1

Description
New technique group: After cesarean section, in patients with chromic suture round 1 of Supa company, the whole layer of the myometrium, the incision site is cut from one centimeter away, and the decidua part is swabbed in both upper and lower parts.
Category
Treatment - Surgery

2

Description
Conventional technique group: The uterus is sutured in two layers, the first layer is lacquered and the second layer is lacquered chrome 1 round without Supa company.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Shahla Nasrolahi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Shahla Nasrolahi
Position
Associate Professor of Perinatology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Dr-nasrolahi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Neda shafie
Position
Resident Gynecology and Obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Neda_shafie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Neda shafie
Position
Resident Gynecology and Obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
Neda_shafie@yahoo.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
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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