Comparison of frequency distribution of niche after cesarean section in 4 methods of single layer and double layer myometrial repair with vicryl and chromic sutures
Design
The clinical trial consisted of 4 intervention groups, double-blind, randomized on a total of 108 patients (each group included 27 patients). Patients were enrolled by convenience sampling method and randomized blocking was performed.
Settings and conduct
In this study, 108 pregnant women referring to the clinic and delivery room of Taleghani Hospital in Tehran who are experiencing their first cesarean section will be included in the study based on inclusion and exclusion criteria. Patients will be placed in one of 4 repair groups (without knowing the repair method). After at least 6 months of cesarean section, they will refer to an ultrasound specialist who specializes in examining cesarean scar niche, who will inform the closure method and will report the size of the niche and the residual myometrium thickness(RMT).
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with a singleton pregnancy over 37 weeks of gestation who will undergo elective or emergency cesarean section for the first time.
Exclusion criteria: chorioamnionitis; history of previous uterine myometrial surgery; classic uterine incision; placenta accreta or pervia.
Intervention groups
Patients will be randomly divided into 4 groups:
Group 1: Single layer closure of kerr incision with continuous_lock vicryl suture.
Group 2: Double layer closure of kerr incision(first layer: continuous lock and second layer: continuous) with vicryl suture.
Group 3: Single layer closure of kerr incision with continuous_lock chromic suture.
Group 4: Double layer closure of kerr incision(first layer: continuous lock and second layer: continuous) with chromic suture.
Main outcome variables
Niche; RMT; single/double-layer myometrial repair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220531055036N1
Registration date:2022-11-14, 1401/08/23
Registration timing:retrospective
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Mahsa Mirhadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2560
Email address
m.a.mirhadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the incidence of cesarean scar niche in 4 methods of myometrial repair in single and double layer with chromic and vicryl sutures
Public title
The effect of myometrial repair technique on the incidence of niche.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First cesarean section
Gesatational age more than 37 weeks
Kerr incision
Singleton pregnancy
Exclusion criteria:
Chorioamnionitis
Previous myometrial surgury
Classic incision
Placenta accreta or previa
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomized
(There are 4 blocks and the number of people in each block is 27 and patients are placed in one block, respectively.)
Blinding (investigator's opinion)
Double blinded
Blinding description
Sonographist and patient are not aware of myometrial repair methods.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti university of medical sciences
The myometrium is repaired in one layer with vicryl no. 1 suture(polyglactin 910).
Category
Treatment - Surgery
2
Description
The myometrium is repaired in two layer with vicryl no. 1 suture(polyglactin 910).
Category
Treatment - Surgery
3
Description
The myometrium is repaired in one layer with chromic no. 1 suture(natural absorbable suture).
Category
Treatment - Surgery
4
Description
The myometrium is repaired in two layer with chromic no. 1 suture(natural absorbable suture).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Mahsasadat Mirhadi
Street address
Erabi Ave., Taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Sahid Beheshi Univerdity of Medical Science, Erabi Ave., Yaman Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsasadat Mirhadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Erabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
M.a.mirhadi @sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsasadat Mirhadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Erabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1111
Email
m.a.mirhadi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahsasadat Mirhadi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hospital, Erabi Ave.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1111
Email
m.a.mirhadi@sbmu.ac.ir
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 except personal information (including patients' names, addresses and telephone numbers) can be shared.
When the data will become available and for how long
Start accessing after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data for research and treatment.
From where data/document is obtainable
M.a.mirhadi@sbmu.ac.ir
Mahsasadat Mirhadi
What processes are involved for a request to access data/document
After confirming the identity of the applicant from the university, information will be made available to him / her in case of non-contradiction with ethical issues and approval of the supervisor.