The aim of present study is to compare NICHE between continious and interrupted methods of cesarean incision repair.
Design
A clinical trial with two parallel groups without blinding, randomized on 70 pregnant mothers, Rand list software will be used for randomization.
Settings and conduct
70 primigravida women who are undergoing cesarean section in Al-Zahra Educational and Medical Center of Tabriz University of Medical Sciences will be randomly divided into two equal groups (35 people in each group) using a random number table. Cesarean section will be repaired using zero vicryl suture in the first group by continuous method and in the second group by intermittent method. Uterine ultrasound will be done one month after surgery to check the surgical site and NICHE development.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: pregnant women aged 18 to 35 years, primigravida, term pregnancy, candidate for elective cesarean section due to pelvic stenosis or abnormal presentation and BMI between 20 and 25. Exclusion criteria are also: chronic systemic disease, using immunosuppressive drug, history of previous cesarean section, amniotic sac rupture, severe bleeding before surgery and impossibility of proper follow-up after surgery.
Intervention groups
Both groups of mothers will be operated cesarean section surgery by a single surgeon with a pfannenstiel incision under sterile conditions and after spinal anesthesia and receiving prophylactic antibiotics according to the protocol of the obstetrics and gynecology department. Cesarean section repair in both groups will be done using zero vicryl sutures, in the first group the repair will be continuous and in the second group it will be intermittent.
Main outcome variables
The primary outcome of the present study are the existence of NICHE; and the size of NICHE.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121022011205N4
Registration date:2021-12-23, 1400/10/02
Registration timing:registered_while_recruiting
Last update:2021-12-23, 1400/10/02
Update count:0
Registration date
2021-12-23, 1400/10/02
Registrant information
Name
Dr.Zahra Fardiazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
fardiazar@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of NICHE between Continious and Interrupted Methods of Cesarean Incision Repair
Public title
Comparison of NICHE between Continious and Interrupted Methods of Cesarean Incision Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18 to 35 years
Primigravida
Term pregnancy
Candidate for elective cesarean section due to pelvic stenosis or abnormal presentation
BMI between 20 and 25
Exclusion criteria:
Chronic systemic disease
Using immunosuppressants
History of previous cesarean section
Amniotic sac rupture
Severe bleeding before surgery
Impossibility of follow-up
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using Rand list version 1.2 software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
IR.TBZMED.REC.1398.885
Health conditions studied
1
Description of health condition studied
Scar of cesarean section on the uterus (NICHE)
ICD-10 code
O34.21
ICD-10 code description
Maternal care for scar from previous cesarean delivery
Primary outcomes
1
Description
Cesarean scar on the uterus (NICHE)
Timepoint
30 to 60 days after surgery
Method of measurement
Uterine ultrasound
Secondary outcomes
1
Description
Infection
Timepoint
After surgery for up to two months after that
Method of measurement
Clinical examination
2
Description
Fever
Timepoint
After surgery for up to two months after that
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group1: Repair of cesarean section on the uterus using VICRYL of supa company (size 0) by continuous method.
Category
Treatment - Surgery
2
Description
Intervention group 2: Repair of cesarean section on the uterus using VICRYL of supa company (size 0) by interrupted method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Zahra Fardiazar
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3553 9161
Email
fardyazar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Parviz Shahabi
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Fardiazar
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3553 9161
Email
fardyazar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Zahra Fardiazar
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
009835539161
Email
fardyazar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Zahra Fardiazar
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 35519161
Email
fardyazar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available