Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures

Study Overview
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Brief Summary
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The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures.

Detailed Description
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The aim of this randomized control trial is to compare the residual myometrial thickness and the depth of cesarean section scar defect after uterine incision closure with barbed or conventional sutures. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures. Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.

Official Title
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Ultrasound Evaluation of Cesarean Scar After Uterotomy Closure With Barbed and Conventional Sutures ; a Randomized Controlled Study

Conditions
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Cesarean Section Scar

Intervention / Treatment
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* Device: Cesarean section incision closure using barbed sutures
* Device: Cesarean section incision closure using conventional sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primigravida patients undergoing transverse lower segment cesarean section Exclusion Criteria: Previous laparotomies Postoperative fever Patients with preterm pregnancies or in labor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cesarean section incision closure using barbed sutures<br>Cesarean section incision is closed using barbed sutures | Device: Cesarean section incision closure using barbed sutures<br>* Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.<br>|
| Active Comparator: Cesarean section incision closure using conventional sutures<br>Cesarean section incision is closed using conventional sutures | Device: Cesarean section incision closure using conventional sutures<br>* Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual myometrial thickness | Thickness of myometrium under the niche | Six months after cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar depth |  | Six months after cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section scar, Barbed suture, Conventional suture