Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are: Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure Myometrial niche formation assessed by MRI performed 4 months after the procedure Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness Post-operative change in hemoglobin Time required for hysterotomy closure The number of extra sutures required to achieve surgeon-acceptable hemostasis Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are: Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique. Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.

Official Title
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Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

Conditions
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Pregnancy Related

Intervention / Treatment
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* Procedure: Uterine layers closed
* Device: Suture Type
* Procedure: Endometrium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Singleton gestation Nonurgent primary or secondary cesarean delivery at greater than 35w6d Body Mass Index (BMI) <35 kg/m^2 Exclusion Criteria: More than 1 prior cesarean delivery Multiple gestation Known coagulation disorder or current use of anti-coagulants Mullerian anomalies Placenta previa

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Layer Closure<br>Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. | Procedure: Uterine layers closed<br>* Uterus closed with 1, 2 or 3 layers<br>Device: Suture Type<br>* Barbed or smooth<br>Procedure: Endometrium<br>* Included or excluded<br>|
| Active Comparator: Double Layer Closure<br>Double layer closure using the following technique: Closure of the full thickness of the myometrium with one (1) Monocryl suture on a CT needle using a running locked technique. The endometrium should be excluded. Imbrication of the first layer with one (1) Monocryl suture on a CT needle using a running un-locked technique | Procedure: Uterine layers closed<br>* Uterus closed with 1, 2 or 3 layers<br>Device: Suture Type<br>* Barbed or smooth<br>Procedure: Endometrium<br>* Included or excluded<br>|
| Active Comparator: Triple Layer Closure<br>Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Closure of the remaining myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique or Closure of the endometrium and 2-4 mm of internal myometrium with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique Closure of the remaining myometrium with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique Closure of the serosa with one (1) 2-0 V-Loc 90 suture on a GS-21 needle using an unlocked technique | Procedure: Uterine layers closed<br>* Uterus closed with 1, 2 or 3 layers<br>Device: Suture Type<br>* Barbed or smooth<br>Procedure: Endometrium<br>* Included or excluded<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myometrial thickness | Residual myometrial thickness at the scar site assessed by MRI performed | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Niche | Myometrial niche formation assessed by MRI performed | 4 months | 
| Scar ratio | Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI | 4 month | 
| Blood loss | Post-operative change in hemoglobin | 1 day | 
| Time for closure | Time required for hysterotomy closure | Immediate | 
| Extra sutures | The number of extra sutures required to achieve surgeon-acceptable hemostasis | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean, Myometrium, scar thickness, niche