To evaluate and compare the effects of double-layer locked and unlocked uterine closure techniques in the incidence of cesarean scar defect following the cesarean section
Design
Two-arm parallel-group randomised trial with blinded postoperative care and outcome assessment, with a random block allocation method
Settings and conduct
Patients who meet the inclusion criteria and are candidates for cesarean section in Imam Khomeini Hospital of Tehran are included in this study and are randomly allocated to Locked or Unlocked. The patient will not be aware of the repair method. Then, one year after the operation, the patients are subjected to sonographic examination by an experienced obstetrician and gynecologist of the center who is not aware of their repair method.
Participants/Inclusion and exclusion criteria
Inclusion criteria
- primiparous term pregnant women in their third trimester
- eligible for primary cesarean section
- possessing a normal pre-pregnancy body mass index
- lacking pre-pregnancy medical conditions
- free from major pregnancy complications like gestational hypertension, preeclampsia, eclampsia, and gestational diabetes mellitus
- not in the latent phase of labor
- presenting with a fetal head station of zero or higher
- no history of prior lower uterine segment surgery.
Exclusion criteria
- extension of the cesarean section incision during the procedure
- Pregnancy during the one-year follow-up period
- patient unwillingness
- patient non-cooperation
Intervention groups
Patients will randomly be assigned to one of two groups: "locked" or "unlocked" uterine closure methods. In the locked group, a two-layer closure was performed, while in the unlocked group, a two-layer closure will be also carried out.
Comparing Cesarean Scar Defect Incidence After Locked and Unlocked Repair Methods Among Primiparous Patients: A Randomized Double-blinded Trial
Public title
Comparing Cesarean Scar Defect Incidence After Locked and Unlocked Repair Methods Among Primiparous Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous term pregnant women in their third trimester
Eligible for primary cesarean section
Possessing a normal pre-pregnancy body mass index (BMI)
Lacking pre-pregnancy medical conditions
Free from major pregnancy complications like gestational hypertension, preeclampsia, eclampsia, and gestational diabetes mellitus
Not in the latent phase of labor
Presenting with a fetal head station of zero or higher (-3, -2, -1, and 0)
No history of prior lower uterine segment surgery
Exclusion criteria:
Extension of the cesarean section incision during the procedure
Pregnancy during the one-year follow-up period
Patient unwillingness
Patient non-cooperation
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to the “locked” and “unlocked” uterine closure methods using a random block allocation method (allocation ratio of 1:1, blocks of four).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the examiner who performed the ultrasonographic assessments were blinded to the surgical closure approach assignments.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Keshavarz Blvd., Quds St., Central Organization of the Tehran University of Medical Sciences, 6th floor, Research and Technology section
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889
Email
Gsia@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Tarafdari Manshadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kehsvarz Blvd, Gharib St, Imam Khomeini Hospital Complex, Vali-e-Asr Hospital, Department of Obstetrics and Gynecology
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
azadehmehr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Tarafdari Manshadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz blvd, Gharib st, Imam Khomeini Hospital Complex, Vali-e-Asr Hospital, Department of Obstetrics and Gynecology
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
0098 21 61190
Email
azadehmehr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadamin Parsaei
Position
Postdoctoral Research Felow
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
3. Vali-E-Asr Reproductive Health Research Center, Family Health Research Institute, Imam Khomeini Hospital Complex, Keshavarz blvd, Gharib st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
0098 66581616
Email
amin.parsaei890@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
Baseline demographic data of the participants and results of their follow-up visits (ultrasonographic examination) would be available in an SPSS file (with a sav. format)
When the data will become available and for how long
Data would be available six months after the publication
To whom data/document is available
Researchers of the university-based research centers
Under which criteria data/document could be used
In cases of proper requests and under our supervision the data would be available.
From where data/document is obtainable
Email address: Amin.parsaei890@gmail.com
What processes are involved for a request to access data/document
Emailing the author and explaining the reason for their request
Confirming the adherence to ethical considerations
Receiving the data via email