Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency

Study Overview
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Brief Summary
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In recent decades, the rate of cesarean section delivery has steadily increased worldwide ranging at 30% of deliveries, thus long-term risks after cesarean section need to be evaluated. Postoperative risks include, among others, uterine scar rupture and placental complications such as placenta previa and accreta- complications, which are possibly associated with uterine scar dehiscence. The prevalence of lower-segment uterine scar deficiency has previously been described as 63%. One recent systematic review and meta analysis investigated closure techniques of low transverse cesarean. No significant difference in risk of uterine scar defect comparing single layer versus double layer closure could be detected (RR 0.53), whereas in women with single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However, the authors do conclude that data is insufficient to determine the risk of uterine rupture, dehiscence or gynecological outcomes due to insufficient power of available studies. A recently published Randomized Controlled Trial concluded that double-layer closure with unlocked first layer showed a better scar healing than locked single layer. The investigators main objective is to identify if single-layer suture of the uterus during cesarean section results in a higher rate of cesarean scar deficiency than double-layer suture. Interventions Single- layer versus double- layer uterine closure Two different techniques of uterine closure in cesarean section will be compared: single- layer versus double- layer continuous uterotomy suture. Standardized transvaginal sonography Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound machine used for all examinations is GE Voluson E10. Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no). Secondary outcome: Myometrial thickness at the site of uterine scar (mm).

Official Title
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Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency: A Randomized Controlled Trial

Conditions
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Cesarean Section, Uterine Scar Deficiency, Myometrial Thickness, Single-layer Continuous Uterotomy Suture, Double-layer Continuous Uterotomy Suture, Transvaginal Ultrasound

Intervention / Treatment
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* Procedure: uterine closure during cesarean section


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First cesarean section Scheduled cesarean section at Department of Obstetrics and Gynecology, Medical University of Vienna Age ≥ 18 years Informed Consent Cesarean section at ≥ 37+0 weeks of gestation Exclusion Criteria: Previous cesarean section Emergency cesarean section Cesarean section < 37+0 weeks of gestation Corporal incision during cesarean section Diseases which favor wound healing disruptions (e.g. chronic inflammatory diseases) Uterine anatomic anomalies BMI > 35kg/m2 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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No

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 continuous uterotomy suture<br>Single-layer continuous uterotomy suture | Procedure: uterine closure during cesarean section<br> <br> |
| Active Comparator: double-layer continuous uterotomy suture<br>double-layer continuous uterotomy suture | Procedure: uterine closure during cesarean section<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no). |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myometrial thickness at the site of uterine scar (mm). |  | 3 months |