Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

Study Overview
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Brief Summary
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There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard. This study compares two techniques of uterine closure on myometrium thickness: Double layer unlocked suture; Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium. The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Official Title
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Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

Conditions
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Uterine Scar Defect

Intervention / Treatment
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* Procedure: Double layer closure of the hysterotomy
* Procedure: Purse closure of the hysterotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned cesarean Primary cesarean ≥ 38 gestational weeks Exclusion Criteria: Previous cesarean Women < 18 years old Multiple gestation Mullerian anomalies Active labor Diabetes BMI >35 kg/m2 Placenta praevia Chronic systemic disease Covid-19 infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double layer unlocked uterine closer<br>Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium. | Procedure: Double layer closure of the hysterotomy<br>* Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.<br>|
| Experimental: Purse uterine closer<br>Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium | Procedure: Purse closure of the hysterotomy<br>* Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual myometrium thickness |  | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | Same day of intervention: day 1 | 
| Estimated blood loss |  | Same day of intervention: day 1 | 
| Mean number of haemostatic sutures |  | Same day of intervention: day 1 | 
| scar width |  | Same day of intervention: day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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niche