Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Study Overview
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Brief Summary
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Late sequelae of a cesarean section related to a uterine scar defects include gynecological symptoms and obstetric complications. The aim of this study was to evaluate the incidence and characteristics of cesarean scar defects after uterine closure by double-layer barbed suture.

Official Title
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A Prospective Pilot Study Comparing Incidence and Characteristics of Cesarean Scar Defects After Uterine Closure by Double-layer Barbed or Smooth Suture

Conditions
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Isthmocele, Uterine Scar Defects, Cesarean Section Complications, Uterine Niche

Intervention / Treatment
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* Procedure: Clinical and ultrasonographic assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients who underwent elective cesarean section at ≥ 37 weeks of gestation Exclusion Criteria: Patients who underwent concomitant surgical procedures during the cesarean section (i.e., tubal sterilization); Patients who underwent a previous abdominal surgery (with exception of appendectomy) including a cesarean section or other laparotomic/laparoscopic uterine surgical procedure (i.e., myomectomy); Patients who had a previous diagnosis of Mullerian uterine anomalies elective cesarean for the second time or after uterine surgery; Patients who had evidence of PAS disorders or placenta previa.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low transverse hysterotomy closed by double-layer unidirectional barbed suture<br>Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by double-layer unidirectional barbed suture | Procedure: Clinical and ultrasonographic assessment<br>* Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures<br>|
| Low transverse hysterotomy closed by conventional double-layer smooth suture<br>Patients who had undergone cesarean section during which the low transverse hysterotomy was closed by conventional double-layer smooth suture | Procedure: Clinical and ultrasonographic assessment<br>* Routinely assessment by objective examination and transvaginal ultrasonographic scan 6, 12, and 24 months after the surgical procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of uterine scar defects | Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound | 6 months after the cesarean section | 
| Number of uterine scar defects | Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound | 12 months after the cesarean section | 
| Number of uterine scar defects | Number of simple and complex uterine scar defects is evaluated by transvaginal ultrasound | 24 months after the cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual myometrium thickness (RMT), depth, width and length of uterine scar defects | RMT, depth, width, and length are evaluated by transvaginal ultrasound | 6 months after the cesarean section | 
| Residual myometrium thickness (RMT), depth, width and length of uterine scar defects | RMT, depth, width, and length are evaluated by transvaginal ultrasound | 12 months after the cesarean section | 
| Residual myometrium thickness (RMT), depth, width and length of uterine scar defects | RMT, depth, width, and length are evaluated by transvaginal ultrasound | 24 months after the cesarean section | 
| Number of patients with postmenstrual spotting | Number of patients with postmenstrual spotting is evaluated by medical interview | 6 months after the cesarean section | 
| Number of patients with postmenstrual spotting | Number of patients with postmenstrual spotting is evaluated by medical interview | 12 months after the cesarean section | 
| Number of patients with postmenstrual spotting | Number of patients with postmenstrual spotting is evaluated by medical interview | 24 months after the cesarean section | 
| Number of patients with dysmenorrhea | Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale) | 6 months after the cesarean section | 
| Number of patients with dysmenorrhea | Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale) | 12 months after the cesarean section | 
| Number of patients with dysmenorrhea | Number of patients with dysmenorrhea is evaluated by medical interview with VAS (visual analogue scale) | 24 months after the cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine scar defects, Uterine niche, Isthmocele