Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

Study Overview
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Brief Summary
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The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

Official Title
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Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

Conditions
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Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness

Intervention / Treatment
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* Procedure: Single layer closure
* Procedure: Double layer closure
* Procedure: Doble layer closure with trimming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous two or three cesarean Gestational weeks >=36 weeks Exclusion Criteria: Risk of obstetric haemorrhage Suspicion or diagnosis placenta previa or accrete syndrome Chorioamnionitis Uterine myoma in the anterior uterine segment Hysterotomy other than lower segment uterine incision at previous cesarean

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single layer closure<br> | Procedure: Single layer closure<br>* Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.<br>|
| Active Comparator: Double layer closure<br> | Procedure: Double layer closure<br>* The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.<br>|
| Active Comparator: Doble layer closure with trimming<br> | Procedure: Doble layer closure with trimming<br>* Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual myometrial thickness | Myometrial thickness at the uterine scar by transvaginal ultrasound | 6 months after cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of cesarean scar defect | The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 2 mm. | 6 months after cesarean | 
| Width of defect | In a sagittal plane, the width at base of defect | 6 months after cesarean | 
| Depth of defect (niche) | In a sagittal plane, the distance from the base lining of the endometrium to the apex | 6 months after cesarean | 
| Operation time | Skin-to-skin operation time | 10 minute after cesarean completed | 
| Change in hemoglobin | Difference in haemoglobin measured preoperatively and postoperatively 48 hours | 48 hours after cesarean | 
| Blood product transfusion | Unite number of transfused packed erythrocyte | One week after cesarean | 
| Maternal infectious morbidity | Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever. | Six weeks after cesarean | 
| Length of hospitalization | Duration in days | One month after cesarean |