Suture of UTerus and Ultrasound Repair Evaluation

Study Overview
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Brief Summary
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This study compares three techniques of uterine closure on myometrium thickness evaluated by ultrasound six months after the primary cesarean. The three techniques include: 1) locked single layer closure; 2) double layer closure with a first continuous locked suture and a second imbricating continuous suture; 3) double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. The primary outcome is the mean myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Official Title
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Randomized Controlled Trial Comparing Three Techniques of Uterine Closure on the Myometrium Thickness Evaluated With Ultrasound Six Months After a Primary Cesarean

Conditions
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Uterine Scar Defect

Intervention / Treatment
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* Procedure: Closure of the hysterotomy at the time of primary cesarean


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

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Unlocked double layer<br>Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium avoiding the inclusion of the decidua and a second unlocked continuous suture that approximate the upper portion of the myometrium. | Procedure: Closure of the hysterotomy at the time of primary cesarean<br> <br> |
| Other: Locked single layer closure<br>As reported in Williams Obstetrics textbook | Procedure: Closure of the hysterotomy at the time of primary cesarean<br> <br> |
| Other: Locked double layer<br>Double layer closure with a first continuous locked suture and a second imbricating continuous suture. | Procedure: Closure of the hysterotomy at the time of primary cesarean<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean myometrium thickness | Using transvaginal ultrasound the residual myometrium thickness at the site of the uterine scar will be measure. | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss |  | Same day of intervention: day 1 | 
| Operative time |  | Same day of intervention: day 1 | 
| Mean number of haemostatic sutures |  | 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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cesarean, ultrasound, hysterotomy, uterus, suture